Computer-implemented system for secure physiological data collection and processing

ABSTRACT

The electrode patch can store an identifier, such as a serial number, and a password associated with the identifier. The password can include a cryptographic hash of the identifier. The password and the identifier are coupled to the data collected using the patch and the data can be stored as electronic medical records (EMR) in a database based on the identifier. A patient or another authorized party can access the data using the identifier and the password. The EMRs can also include results of analysis of data received from the monitor, such as an automated over-read of an ECG trace based on the received data.

CROSS-REFERENCE TO RELATED APPLICATION

This present non-provisional patent application is acontinuation-in-part of U.S. patent application Ser. No. 14/341,698,filed Jul. 25, 2014, pending; which is a continuation-in-part of U.S.patent application Ser. No. 14/082,071, filed Nov. 15, 2013, issued asU.S. Pat. No. 9,433,367 on Sep. 6, 2016; which is a continuation-in-partof U.S. patent application Ser. No. 14/080,717, filed Nov. 14, 2013,pending, and a continuation-in-part of U.S. patent application Ser. No.14/080,725, filed Nov. 14, 2013, pending; and which further claimspriority under 35 U.S.C. §119(e) to U.S. Provisional Patent application,Ser. No. 61/882,403, filed Sep. 25, 2013, the disclosures of which areincorporated by reference; this present non-provisional patentapplication is also a continuation-in-part of U.S. patent applicationSer. No. 14/488,230, filed Sep. 16, 2014, pending; which is acontinuation-in-part of U.S. patent application Ser. No. 14/080,725,filed Nov. 14, 2013, pending, and further claims priority under 35U.S.C. ±§119(e) to U.S. Provisional Patent application, Ser. No.61/882,403, filed Sep. 25, 2013, the disclosures of which areincorporated by reference.

FIELD

This application relates in general to electrocardiography and, inparticular, to a computer-implemented system and method for securephysiological data collection and processing.

BACKGROUND

The first electrocardiogram (ECG) was invented by a Dutch physiologist,Willem Einthoven, in 1903, who used a string galvanometer to measure theelectrical activity of the heart. Generations of physicians around theworld have since used ECGs, in various forms, to diagnose heart problemsand other potential medical concerns. Although the basic principlesunderlying Dr. Einthoven's original work, including his naming ofvarious waveform deflections (Einthoven's triangle), are stillapplicable today, ECG machines have evolved from his original three-leadECG, to ECGs with unipolar leads connected to a central referenceterminal starting in 1934, to augmented unipolar leads beginning in1942, and finally to the 12-lead ECG standardized by the American HeartAssociation in 1954 and still in use today. Further advances inportability and computerized interpretation have been made, yet theelectronic design of the ECG recording apparatuses has remainedfundamentally the same for much of the past 40 years.

Essentially, an ECG measures the electrical signals emitted by the heartas generated by the propagation of the action potentials that triggerdepolarization of heart fibers. Physiologically, transmembrane ioniccurrents are generated within the heart during cardiac activation andrecovery sequences. Cardiac depolarization originates high in the rightatrium in the sinoatrial (SA) node before spreading leftward towards theleft atrium and inferiorly towards the atrioventricular (AV) node. Aftera delay occasioned by the AV node, the depolarization impulse transitsthe Bundle of His and moves into the right and left bundle branches andPurkinje fibers to activate the right and left ventricles.

During each cardiac cycle, the ionic currents create an electrical fieldin and around the heart that can be detected by ECG electrodes placed onthe skin. Cardiac electrical activity is then visually represented in anECG trace by PQRSTU-waveforms. The P-wave represents atrial electricalactivity, and the QRSTU components represent ventricular electricalactivity. Specifically, a P-wave represents atrial depolarization, whichcauses atrial contraction.

P-wave analysis based on ECG monitoring is critical to accurate cardiacrhythm diagnosis and focuses on localizing the sites of origin andpathways of arrhythmic conditions. P-wave analysis is also used in thediagnosis of other medical disorders, including imbalance of bloodchemistry. Cardiac arrhythmias are defined by the morphology of P-wavesand their relationship to QRS intervals. For instance, atrialfibrillation (AF), an abnormally rapid heart rhythm, can be confirmed bythe presence of erratic atrial activity or the absence of distinctP-waves and an irregular ventricular rate. Atrial flutter can bediagnosed with characteristic “sawtooth” P-waves often occurring twicefor each QRS wave. Some congenital supraventricular tachycardias, likeAV node re-entry and atrioventricular reentrant tachycardia using aconcealed bypass tract, are characterized by an inverted P-waveoccurring shortly after the QRS wave. Similarly, sinoatrial block ischaracterized by a delay in the onset of P-waves, while junctionalrhythm, an abnormal heart rhythm resulting from impulses coming from alocus of tissue in the area of the AV node, usually presents withoutP-waves or with inverted P-waves within or shortly before or after theQRS wave. Also, the amplitudes of P-waves are valuable for diagnosis.The presence of broad, notched P-waves can indicate left atrialenlargement or disease. Conversely, the presence of tall, peakedP-waves, especially in the initial half, can indicate right atrialenlargement. Finally, P-waves with increased amplitude can indicatehypokalemia, caused by low blood potassium, whereas P-waves withdecreased amplitude can indicate hyperkalemia, caused by elevated bloodpotassium.

Cardiac rhythm disorders may present with lightheadedness, fainting,chest pain, hypoxia, syncope, palpitations, and congestive heart failure(CHF), yet rhythm disorders are often sporadic in occurrence and may notshow up in-clinic during a conventional 12-second ECG. Some atrialrhythm disorders, like atrial fibrillation, are known to cause stroke,even when intermittent. Continuous ECG monitoring with P-wave-centricaction potential acquisition over an extended period is more apt tocapture sporadic cardiac events that can be specifically identified anddiagnosed. However, recording sufficient ECG and related physiologicaldata over an extended period remains a significant challenge, despite anover 40-year history of ambulatory ECG monitoring efforts combined withno appreciable improvement in P-wave acquisition techniques since Dr.Einthoven's original pioneering work over a 110 years ago.

Electrocardiographic monitoring over an extended period provides aphysician with the kinds of data essential to identifying the underlyingcause of sporadic cardiac conditions, especially rhythm disorders, andother physiological events of potential concern. A 30-day observationperiod is considered the “gold standard” of monitoring by some, yet a14-day observation period is currently deemed more achievable byconventional ECG monitoring approaches. Realizing a 30-day observationperiod has proven unworkable with existing ECG monitoring systems, whichare arduous to employ; cumbersome, uncomfortable and not user-friendlyto the patient; and costly to manufacture and deploy. An intractableproblem is the inability to have the monitoring electrodes adhere to theskin for periods of time exceeding 5-14 days, let alone 30 days. Still,if a patient's ECG could be recorded in an ambulatory setting over aprolonged time periods, particularly for more than 14 days, the chancesof acquiring meaningful medical information and capturing an abnormalevent while the patient is engaged in normal activities are greatlyimproved.

The location of the atria and their low amplitude, low frequency contentelectrical signals make P-waves difficult to sense, particularly throughambulatory ECG monitoring. The atria are located either immediatelybehind the mid sternum (upper anterior right atrium) or posteriorlywithin the chest (left atrium), and their physical distance from theskin surface, especially when standard ECG monitoring locations areused, adversely affects current strength and signal fidelity. Cardiacelectrical potentials measured from the classical dermal locations havean amplitude of only one-percent of the amplitude of transmembraneelectrical potentials. The distance between the heart and ECG electrodesreduces the magnitude of electrical potentials in proportion to thesquare of change in distance, which compounds the problem of sensing lowamplitude P-waves. Moreover, the tissues and structures that lie betweenthe activation regions within the heart and the body's surface furtherattenuate the cardiac electrical field due to changes in the electricalresistivity of adjacent tissues. Thus, surface electrical potentials,when even capable of being accurately detected, are smoothed over inaspect and bear only a general spatial relationship to actual underlyingcardiac events, thereby complicating diagnosis. Conventional 12-leadECGs attempt to compensate for weak P-wave signals by monitoring theheart from multiple perspectives and angles, while conventionalambulatory ECGs primarily focus on monitoring higher amplitudeventricular activity, i.e., the R-wave, that, comparatively, can bereadily sensed. Both approaches are relatively unsatisfactory withrespect to the P-wave and related need for the accurate acquisition ofthe P and R-wave medically actionable data of the myriad cardiac rhythmdisorders that exist.

Additionally, maintaining continual contact between ECG electrodes andthe skin after a day or two of ambulatory ECG monitoring has been aproblem. Time, dirt, moisture, and other environmental contaminants, aswell as perspiration, skin oil, and dead skin cells from the patient'sbody, can get between an ECG electrode's non-conductive adhesive and theskin's surface. These factors adversely affect electrode adhesion whichin turn adversely affects the quality of cardiac signal recordings.Furthermore, the physical movements of the patient and their clothingimpart various compressional, tensile, bending, and torsional forces onthe contact point of an ECG electrode, especially over long recordingtimes, and an inflexibly fastened ECG electrode will be prone tobecoming dislodged or unattached. Moreover, subtle dislodgment may occurand be unbeknownst to the patient, making the ECG recordings worthless.Further, some patients may have skin that is susceptible to itching orirritation, and the wearing of ECG electrodes can aggravate such skinconditions. Thus, a patient may want or need to periodically remove orreplace ECG electrodes during a long-term ECG monitoring period, whetherto replace a dislodged electrode, reestablish better adhesion, alleviateitching or irritation, allow for cleansing of the skin, allow forshowering and exercise, or for other purpose. Such replacement or slightalteration in electrode location actually facilitates the goal ofrecording the ECG signal for long periods of time.

Conventionally, multi-week or multi-month monitoring can be performed byimplantable ECG monitors, such as the Reveal LINQ insertable cardiacmonitor, manufactured by Medtronic, Inc., Minneapolis, Minn. Thismonitor can detect and record paroxysmal or asymptomatic arrhythmias forup to three years. However, like all forms of implantable medical device(IMD), use of this monitor requires invasive surgical implantation,which significantly increases costs; requires ongoing follow up by aphysician throughout the period of implantation; requires specializedequipment to retrieve monitoring data; and carries complicationsattendant to all surgery, including risks of infection, injury or death.Finally, such devices do not necessarily avoid the problem of signalnoise and recording high quality signals.

Holter monitors are widely used for ambulatory ECG monitoring.Typically, they are used for only 24-48 hours. A typical Holter monitoris a wearable and portable version of an ECG that includes cables foreach electrode placed on the skin and a separate battery-powered ECGrecorder. The leads are placed in the anterior thoracic region in amanner similar to what is done with an in-clinic standard ECG machineusing electrode locations that are not specifically intended for optimalP-wave capture but more to identify events in the ventricles bycapturing the R-wave. The duration of monitoring depends on the sensingand storage capabilities of the monitor. A “looping” Holter (or event)monitor can operate for a longer period of time by overwriting older ECGtracings, thence “recycling” storage in favor of extended operation, yetat the risk of losing event data. Although capable of extended ECGmonitoring, Holter monitors are cumbersome, expensive and typically onlyavailable by medical prescription, which limits their usability.Further, the skill required to properly place the electrodes on thepatient's chest precludes a patient from replacing or removing thesensing leads and usually involves moving the patient from the physicianoffice to a specialized center within the hospital or clinic.

Noise in recorded signals or other artifacts that do not reflect cardiacactivity can contribute to an incorrect diagnosis of a patient. The mainsources of noise in an ECG machine are common mode noise, such as 60 Hzpower line noise, baseline wander, muscle noise, and radio frequencynoise from equipment including pacemakers or other implanted medicaldevices. Such noise can contribute to an incorrect diagnosis of thepatient. For example, electrical or mechanical artifacts, such asproduced by poor electrode contact or tremors, can simulatelife-threatening arrhythmias. Similarly, baseline wander produced byexcessive body motion during an ECG procedure may simulate an ST segmentshift ordinarily seen in myocardial ischemia or injury.

Current ECG over-reading software generally does not allow a user toapply an arbitrary noise filter of choice to an ECG trace; users aregenerally limited to a set of proprietary filters. In addition,conventional over-reading software generally fails to provide users witha way to compare the results of combinations of arbitrary noise filters,thus preventing the user from finding the most appropriate filter. Thisis especially relevant when trying to record the P-wave or cardiacatrial signal. Further, the interpretation of the ECG is conventionallyleft entirely to the user, such as a technician or a doctor, and thespeed with which a patient can receive some interpretation results ofhis or her ECG depends entirely on when the user can get to thatpatient's ECG and how much time the interpretation consumes. In anenvironment where medical personnel resources are scarce, theinterpretation may take an excessively long time.

Further, in addition to ECG signal acquisition and processing,significant challenges exist in regards to the storage of the results ofacquisition and processing and making such results quickly available toonly authorized parties, such as the patient or the patient's physician.Multiple laws govern the safeguarding of electronic patient records. Forexample, in the United States, the governing law includes HealthInsurance Portability and Accountability Act (HIPAA) while in theEuropean Union the law includes the European Union's Data ProtectionDirective. In particular, such laws, and HIPAA in particular, focusprotection on individually identifiable health information, informationthat can be tied to a particular patient. Such patient identifyinginformation can include information on the patient's physical or mentalhealth, provision of care to the patient, payment for provision ofhealth care, and identifying information such as name, address, birthdate, and social security number. Disclosure of such information inbreach of the applicable laws can incur significant penalties.Considering that the disclosure can happen through ways as diverse as ahack of a database containing the records, personnel error, and loss ofaccess information for the database, significant potential for anillegal disclosure exists with conventional record storage techniques.

Therefore, a need remains for a way to facilitate real-time, interactiveprocessing of an ECG.

An additional need exists to accelerate ECG over-reading.

A still further need remains for a way to securely store and provideaccess to results of ECG analyses and other identifying information.

A further need remains for a low cost extended wear continuouslyrecording ECG monitor attuned to capturing low amplitude cardiac actionpotential propagation for arrhythmia diagnosis, particularly atrialactivation P-waves, and practicably capable of being worn for a longperiod of time, especially in patient's whose breast anatomy or size caninterfere with signal quality in both women and men.

SUMMARY

An ECG is displayed to a user, and a user selection of a desired portionof the ECG is received. A list of filters is provided to the user, andthe user can try applying different filters to the selection byselecting of one or more sets of the filters in the list. For each ofthe sets, the filters are applied to digitized signals corresponding tothe selection, a filtered ECG for the selection is generated based onthe signals filtered by each of the sets, and the filtered selection ECGtraces are displayed to the user. The filtered selections can bedisplayed side-by-side, allowing the user to compare the ECG traces ofthe selection filtered using the different sets of filters, and todecide whether application of certain filters resulted in aneasily-interpretable ECG, or whether different filters need to beapplied. As the result, the user can select the most appropriate filtersfor the selection, which facilitates removal of noise and enhancement ofECG features that were corrupted by noise or were made difficult to seedue to the amplitude of the noise. In addition, by applying the filtersto only a particular selection, the user is permitted to filter theselection without degrading the quality of other portions of the ECG.

Physiological monitoring can be provided through a lightweight wearablemonitor that includes two components, a flexible extended wear electrodepatch and a reusable monitor recorder that removably snaps into areceptacle on the electrode patch. The wearable monitor sits centrally(in the midline) on the patient's chest along the sternum orientedtop-to-bottom. The ECG electrodes on the electrode patch are tailored tobe positioned axially along the midline of the sternum for capturingaction potential propagation in an orientation that corresponds to theaVF lead used in a conventional 12-lead ECG that is used to sensepositive or upright P-waves. The placement of the wearable monitor in alocation at the sternal midline (or immediately to either side of thesternum), with its unique narrow “hourglass”-like shape, significantlyimproves the ability of the wearable monitor to cutaneously sensecardiac electrical potential signals, particularly the P-wave (or atrialactivity) and, to a lesser extent, the QRS interval signals indicatingventricular activity in the ECG waveforms.

Moreover, the electrocardiography monitor offers superior patientcomfort, convenience and user-friendliness. The electrode patch isspecifically designed for ease of use by a patient (or caregiver);assistance by professional medical personnel is not required. Thepatient is free to replace the electrode patch at any time and need notwait for a doctor's appointment to have a new electrode patch placed.Patients can easily be taught to find the familiar physical landmarks onthe body necessary for proper placement of the electrode patch.Empowering patients with the knowledge to place the electrode patch inthe right place ensures that the ECG electrodes will be correctlypositioned on the skin, no matter the number of times that the electrodepatch is replaced. In addition, the monitor recorder operatesautomatically and the patient only need snap the monitor recorder intoplace on the electrode patch to initiate ECG monitoring. Thus, thesynergistic combination of the electrode patch and monitor recordermakes the use of the electrocardiography monitor a reliable andvirtually foolproof way to monitor a patient's ECG and physiology for anextended, or even open-ended, period of time.

The electrode patch can store an identifier, such as a serial number,and a password associated with the identifier. The password can includea cryptographic hash of the identifier. The password and the identifierare coupled to the data collected using the patch and the data can bestored as electronic medical records (EMR) in a database based on theidentifier, with the database storing no patient identifyinginformation. In a further embodiment, information needed to send analert to a patient or another authorized party, such as a patient'sdoctor can be stored in the database. A patient or another authorizedparty can access the data using the identifier and the password. TheEMRs can also include results of analysis of data received from themonitor, such as an automated over-read of an ECG trace based on thereceived data.

One embodiment provides a computer-implemented system for securephysiological data collection and processing. The system includes anextended wear electrocardiography and physiological sensor monitorrecorder, which includes: a sealed housing adapted to be removablysecured into a non-conductive receptacle on one of a plurality ofdisposable extended wear electrode patches, each of the patches storingone of a plurality of identifiers, the identifier associated with thepatch, and a password associated with the identifier; and an electroniccircuitry included within the sealed housing. The circuitry includes anelectrocardiographic front end circuit electrically interfaced to themicro-controller and operable to sense electrocardiographic signalsthrough electrocardiographic electrodes provided on the disposableextended wear electrode patch, each of the electrocardiographicelectrodes adapted to be positioned axially along the midline of thesternum for capturing action potential propagation; anexternally-powered micro-controller electrically interfaced to the frontend and operable to execute under micro programmable control throughfirmware that is stored in a program memory unit of themicro-controller, the micro-controller operable to retrieve the passwordand the identifier from the electrode patch; and an externally-poweredflash memory electrically interfaced with the micro-controller andoperable to store and associate the password, the identifier, and thesamples of the electrocardiographic signals.

A further embodiment includes a computer-implemented system for securelow amplitude cardiac action potential data collection and processing.The system includes a disposable extended wear electrode patch and anambulatory electrocardiography monitor. The disposable extended wearelectrode patch includes a flexible backing comprising stretchablematerial defined as an elongated strip with a narrow longitudinalmidsection, each end of the flexible backing comprising an adhesivecontact surface adapted to serve as a crimp relief; a pair ofelectrocardiographic electrodes comprised on the contact surface of eachend of the flexible backing, each electrocardiographic electrodeconductively exposed for dermal adhesion and adapted to be positionedaxially along the midline of the sternum for capturing action potentialpropagation; a non-conductive receptacle affixed to a non-contactingsurface of the flexible backing and comprising an electro mechanicaldocking interface; a pair of flexible circuit traces affixed at each endof the flexible backing with each circuit trace connecting one of theelectrocardiographic electrodes to the docking interface, at least oneof the circuit traces adapted to extend along the narrow longitudinalmidsection to serve as a strain relief; and a circuit operable to storeone of a plurality of identifiers, the identifier associated with thepatch, and a password associated with that identifier. The ambulatoryelectrocardiography monitor includes a wearable housing adapted tosecurely fit into the receptacle; and electronic circuitry providedwithin the wearable housing and comprising an external interfaceconfigured to be removably connected to the electrocardiographicelectrodes via the docking interface, further including: a low powermicrocontroller operable to execute over an extended period undermodular micro program control as specified in firmware and furtheroperable to retrieve the identifier and the password from the circuit;an electrocardiographic front end circuit under the control of themicrocontroller adapted to sense cardiac electrical potentialdifferentials through the electrocardiographic electrodes, which areprovided to the microcontroller as electrocardiographic signalsrepresentative of amplitudes of the action potential propagation; and anon-volatile memory electrically interfaced with the microcontroller andoperable to continuously store samples of the electrocardiographicsignals collected throughout the extended period and to associate thestored samples with the retrieved password and the identifier.

The foregoing aspects enhance ECG monitoring performance and quality byfacilitating long-term ECG recording, which is critical to accuratearrhythmia and cardiac rhythm disorder diagnoses.

Providing a real-time, interactive ECG processing apparatus and methodfor a user, such as a cardiologist or a trained technician, to selectand apply ECG noise filters to a desired portion of an ECG trace,particularly but not exclusively the P-wave, simplifies ECG resultprocessing and improves ECG interpretation accuracy.

The monitoring patch is especially suited to the female anatomy,although also easily used over the male sternum. The narrow longitudinalmidsection can fit nicely within the inter-mammary cleft of the breastswithout inducing discomfort, whereas conventional patch electrodes arewide and, if adhered between the breasts, would cause chafing,irritation, discomfort, and annoyance, leading to low patientcompliance.

In addition, the foregoing aspects enhance comfort in women (and certainmen), but not irritation of the breasts, by placing the monitoring patchin the best location possible for optimizing the recording of cardiacsignals from the atrium, particularly P-waves, which is another featurecritical to proper arrhythmia and cardiac rhythm disorder diagnoses.

Still other embodiments of the present invention will become readilyapparent to those skilled in the art from the following detaileddescription, wherein are described embodiments by way of illustratingthe best mode contemplated for carrying out the invention. As will berealized, the invention is capable of other and different embodimentsand its several details are capable of modifications in various obviousrespects, all without departing from the spirit and the scope of thepresent invention. Accordingly, the drawings and detailed descriptionare to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are diagrams showing, by way of examples, an extended wearelectrocardiography monitor, including an extended wear electrode patch,respectively fitted to the sternal regions of a female patient and amale patient.

FIG. 3 is a front anatomical view showing, by way of illustration, thelocations of the heart and lungs within the rib cage of an adult human.

FIG. 4 is a diagram showing a monitor patch label that can be used toaccess results of physiological monitoring, in accordance with oneembodiment.

FIG. 5 is a perspective view showing an extended wear electrode patchwith a monitor recorder inserted.

FIG. 6 is a perspective view showing the monitor recorder of FIG. 5.

FIG. 7 is a perspective view showing the extended wear electrode patchof FIG. 5 without a monitor recorder inserted.

FIG. 8 is a bottom plan view of the monitor recorder of FIG. 5.

FIG. 9 is a top view showing the flexible circuit of the extended wearelectrode patch of FIG. 5 when mounted above the flexible backing.

FIG. 10 is a functional block diagram showing the component architectureof the circuitry of the monitor recorder of FIG. 5.

FIG. 11 is a functional block diagram showing the signal processingfunctionality of the microcontroller in accordance with one embodiment.

FIG. 12 is a functional block diagram showing the circuitry of theextended wear electrode patch of FIG. 5.

FIG. 13 is a schematic diagram showing the ECG front end circuit of thecircuitry of the monitor recorder of FIG. 10 in accordance with oneembodiment.

FIG. 14 is a flow diagram showing a monitor recorder-implemented methodfor monitoring ECG data for use in the monitor recorder of FIG. 5.

FIG. 15 is a graph showing, by way of example, a typical ECG waveform.

FIG. 16 is a graph showing, by way of example, an ECG waveform of apatient with atrial flutter for a single cardiac cycle, where the ECGwaveform has been corrupted by power line noise.

FIG. 17 is a diagram showing a screen shot generated by an applicationfor interactive processing of ECG data in accordance with oneembodiment.

FIG. 18 is a flow diagram showing a method for interactive processing ofECG data in accordance with one embodiment.

FIG. 19 is a flow diagram showing a routine for recommending an ECGfilter for use in the method of FIG. 18 in accordance with oneembodiment.

FIG. 20 is a functional block diagram showing a computer-implementedsystem for secure physiological data collection and processing inaccordance with one embodiment.

FIG. 21 is a functional block diagram showing operations performed bythe download station in accordance with one embodiment.

FIG. 22 is a flow diagram showing a method for offloading and convertingECG and other physiological data from an extended wearelectrocardiography and physiological sensor monitor in accordance withone embodiment.

DETAILED DESCRIPTION

Physiological monitoring can be provided through a wearable monitor thatincludes two components, a flexible extended wear electrode patch and aremovable reusable monitor recorder. Both the electrode patch and themonitor recorder are optimized to capture electrical signals from thepropagation of low amplitude, relatively low frequency content cardiacaction potentials, particularly the P-waves generated during atrialactivation. FIGS. 1 and 2 are diagrams showing, by way of example, anextended wear electrocardiography and physiological sensor monitor 12,including a monitor recorder 14 in accordance with one embodiment,respectively fitted to the sternal region of a female patient 10 and amale patient 11. The wearable monitor 12 sits centrally (in the midline)on the patient's chest along the sternum 13 oriented top-to-bottom withthe monitor recorder 14 preferably situated towards the patient's head.In a further embodiment, the orientation of the wearable monitor 12 canbe corrected post-monitoring, as further described infra. The electrodepatch 15 is shaped to fit comfortably and conformal to the contours ofthe patient's chest approximately centered on the sternal midline 16 (orimmediately to either side of the sternum 13). The distal end of theelectrode patch 15 extends towards the Xiphoid process and, dependingupon the patient's build, may straddle the region over the Xiphoidprocess. The proximal end of the electrode patch 15, located under themonitor recorder 14, is below the manubrium and, depending uponpatient's build, may straddle the region over the manubrium.

During ECG monitoring, the amplitude and strength of action potentialssensed on the body's surface are affected to varying degrees by cardiac,cellular, extracellular, vector of current flow, and physical factors,like obesity, dermatitis, large breasts, and high impedance skin, as canoccur in dark-skinned individuals. Sensing along the sternal midline 16(or immediately to either side of the sternum 13) significantly improvesthe ability of the wearable monitor 12 to cutaneously sense cardiacelectric signals, particularly the P-wave (or atrial activity) and, to alesser extent, the QRS interval signals in the ECG waveforms thatindicate ventricular activity by countering some of the effects of thesefactors.

The ability to sense low amplitude, low frequency content body surfacepotentials is directly related to the location of ECG electrodes on theskin's surface and the ability of the sensing circuitry to capture theseelectrical signals. FIG. 3 is a front anatomical view showing, by way ofillustration, the locations of the heart 4 and lungs 5 within the ribcage of an adult human. Depending upon their placement locations on thechest, ECG electrodes may be separated from activation regions withinthe heart 4 by differing combinations of internal tissues and bodystructures, including heart muscle, intracardiac blood, the pericardium,intrathoracic blood and fluids, the lungs 5, skeletal muscle, bonestructure, subcutaneous fat, and the skin, plus any contaminants presentbetween the skin's surface and electrode signal pickups. The degree ofamplitude degradation of cardiac transmembrane potentials increases withthe number of tissue boundaries between the heart 4 and the skin'ssurface that are encountered. The cardiac electrical field is degradedeach time the transmembrane potentials encounter a physical boundaryseparating adjoining tissues due to differences in the respectivetissues' electrical resistances. In addition, other non-spatial factors,such as pericardial effusion, emphysema or fluid accumulation in thelungs, as further explained infra, can further degrade body surfacepotentials.

Internal tissues and body structures can adversely affect the currentstrength and signal fidelity of all body surface potentials, yet lowamplitude cardiac action potentials, particularly the P-wave with anormative amplitude of less than 0.25 microvolts (mV) and a normativeduration of less than 120 milliseconds (ms), are most apt to benegatively impacted. The atria 6 are generally located posteriorlywithin the thoracic cavity (with the exception of the anterior rightatrium and right atrial appendage), and, physically, the left atriumconstitutes the portion of the heart 4 furthest away from the surface ofthe skin on the anterior chest. Conversely, the ventricles 7, whichgenerate larger amplitude signals, generally are located anteriorly withthe anterior right ventricle and most of the left ventricle situatedrelatively close to the skin surface on the anterior chest, whichcontributes to the relatively stronger amplitudes of ventricularwaveforms. Thus, the quality of P-waves (and other already-low amplitudeaction potential signals) is more susceptible to weakening fromintervening tissues and structures than the waveforms associated withventricular activation.

The importance of the positioning of ECG electrodes along the sternalmidline 15 has largely been overlooked by conventional approaches to ECGmonitoring, in part due to the inability of their sensing circuitry toreliably detect low amplitude, low frequency content electrical signals,particularly in P-waves. In turn, that inability to keenly sense P-waveshas motivated ECG electrode placement in other non-sternal midlinethoracic locations, where the QRSTU components of the ECG that representventricular electrical activity are more readily detectable by theirsensing circuitry than P-waves. In addition, ECG electrode placementalong the sternal midline 15 presents major patient wearabilitychallenges, such as fitting a monitoring ensemble within the narrowconfines of the inter-mammary cleft between the breasts, that to largeextent drive physical packaging concerns, which can be incompatible withECG monitors intended for placement, say, in the upper pectoral regionor other non-sternal midline thoracic locations. In contrast, thewearable monitor 12 uses an electrode patch 15 that is specificallyintended for extended wear placement in a location at the sternalmidline 16 (or immediately to either side of the sternum 13). Whencombined with a monitor recorder 14 that uses sensing circuitryoptimized to preserve the characteristics of low amplitude cardiacaction potentials, especially those signals from the atria, as furtherdescribed infra with reference to FIG. 13, the electrode patch 15 helpsto significantly improve atrial activation (P-wave) sensing throughplacement in a body location that robustly minimizes the effects oftissue and body structure.

Referring back to FIGS. 1 and 2, the placement of the wearable monitor12 in the region of the sternal midline 13 puts the ECG electrodes ofthe electrode patch 15 in locations better adapted to sensing andrecording low amplitude cardiac action potentials during atrialpropagation (P-wave signals) than placement in other locations, such asthe upper left pectoral region, as commonly seen in most conventionalambulatory ECG monitors. The sternum 13 overlies the right atrium of theheart 4. As a result, action potential signals have to travel throughfewer layers of tissue and structure to reach the ECG electrodes of theelectrode patch 15 on the body's surface along the sternal midline 13when compared to other monitoring locations, a distinction that is ofcritical importance when capturing low frequency content electricalsignals, such as P-waves.

Moreover, cardiac action potential propagation travels simultaneouslyalong a north-to-south and right-to-left vector, beginning high in theright atrium and ultimately ending in the posterior and lateral regionof the left ventricle. Cardiac depolarization originates high in theright atrium in the SA node before concurrently spreading leftwardtowards the left atrium and inferiorly towards the AV node. The ECGelectrodes of the electrode patch 15 are placed with the upper orsuperior pole (ECG electrode) along the sternal midline 13 beneath themanubrium and the lower or inferior pole (ECG electrode) along thesternal midline 13 in the region of the Xiphoid process 9 and lowersternum. The ECG electrodes are placed primarily in a head-to-footorientation along the sternum 13 that corresponds to the head-to-footwaveform vector exhibited during atrial activation. This orientationcorresponds to the aVF lead used in a conventional 12-lead ECG that isused to sense positive or upright P-waves.

Furthermore, the thoracic region underlying the sternum 13 along themidline 16 between the manubrium 8 and Xiphoid process 9 is relativelyfree of lung tissue, musculature, and other internal body structuresthat could occlude the electrical signal path between the heart 4,particularly the atria, and ECG electrodes placed on the surface of theskin. Fewer obstructions means that cardiac electrical potentialsencounter fewer boundaries between different tissues. As a result, whencompared to other thoracic ECG sensing locations, the cardiac electricalfield is less altered when sensed dermally along the sternal midline 13.As well, the proximity of the sternal midline 16 to the ventricles 7facilitates sensing of right ventricular activity and provides superiorrecordation of the QRS interval, again, in part due to the relativelyclear electrical path between the heart 4 and the skin surface.

Finally, non-spatial factors can affect transmembrane action potentialshape and conductivity. For instance, myocardial ischemia, an acutecardiac condition, can cause a transient increase in blood perfusion inthe lungs 5. The perfused blood can significantly increase electricalresistance across the lungs 5 and therefore degrade transmission of thecardiac electrical field to the skin's surface. However, the placementof the wearable monitor 12 along the sternal midline 16 in theinter-mammary cleft between the breasts is relatively resilient to theadverse effects to cardiac action potential degradation caused byischemic conditions as the body surface potentials from a locationrelatively clear of underlying lung tissue and fat help compensate forthe loss of signal amplitude and content. The monitor recorder 14 isthus able to record the P-wave morphology that may be compromised bymyocardial ischemia and therefore make diagnosis of the specificarrhythmias that can be associated with myocardial ischemia moredifficult.

The placement of the wearable monitor 12 in a location at the sternalmidline 16 (or immediately to either side of the sternum 13)significantly improves the ability of the wearable monitor 12 tocutaneously sense cardiac electric signals, particularly the P-wave (oratrial activity) and, to a lesser extent, the QRS interval signals inthe ECG waveforms that indicate ventricular activity, whilesimultaneously facilitating comfortable long-term wear for many weeks.The sternum 13 overlies the right atrium of the heart and the placementof the wearable monitor 12 in the region of the sternal midline 13 putsthe ECG electrodes of the electrode patch 15 in a location betteradapted to sensing and recording P-wave signals than other placementlocations, say, the upper left pectoral region or lateral thoracicregion or the limb leads. In addition, placing the lower or inferiorpole (ECG electrode) of the electrode patch 15 over (or near) theXiphoid process facilitates sensing of ventricular activity and providesexcellent recordation of the QRS interval as the Xiphoid processoverlies the apical region of the ventricles.

At least one component of the monitor 12 can be associated with at anidentifier, such as a serial number, though other kinds of numerical,alphabetical, and alphanumerical identifiers are also possible. Stillother kinds of identifiers are also possible. As described below, theidentifiers of the patch are associated with results of the monitoringperformed using that patch 15 and are used to store and access theresults. FIG. 4 is a diagram showing a monitor patch label 200 that canbe used to access results of physiological monitoring, in accordancewith one embodiment. The label can be given to a patient and otherauthorized parties upon a dispatch of the monitor 12 to the patient. Thelabel 200 includes the identifier 201 associated with at least onecomponent of the monitor 12. For example, as described further below,the identifier 201 can be encoded on the patch 15 and combined with thedata collected by the monitor recorder 14 through the patch 15. Thus, ifmultiple patches 15 are dispensed to the patient, multiple labels 200with multiple identifiers 201 will be issued to the patient 10, 11 andother authorized parties. As the patches 15 do not get reused after amonitoring, the monitoring results of different patients will havedifferent identifiers 201 associated with them even if they wereobtained using the same monitor recorder 14. While the identifier 201 isshown to have eight components with reference to FIG. 4, other numbersof components are possible.

The label 200 further includes a password 202, also referred to as anaccess token 202 in the description below, that is also necessary toaccess the monitoring results. The password 202 can be based on theidentifier 202 associated with the patch 15. For example, the password202 can include a cryptographic hash of at least a portion of theidentifier 201 combined with other digits or numbers. The encryption ofthe identifier 201 can be performed using any suitable encryptionhashing function, such as MD5, though other kinds of functions can alsobe used. In one embodiment, only a portion of the identifier 201, suchas 2-3 bytes, are used to create the hash. In a further embodiment, theentire identifier 201 is used to create the hash. The numbers with whichthe hash can be combined to generate the password can be pseudorandomlygenerated numbers, though other kinds of numbers are possible. Otherkinds of passwords 202 are possible. In one embodiment, the password 202can be composed of 10 digits; other numbers of digits are possible.Still other kinds of the passwords 202 are possible.

The label 200 further includes a website address 203, such as a url,that the party in possession of the label 200 can use to access theElectronic Medical Records (EMR) that include the monitoring results andother data related to the results, as further described below. With allthree pieces of information on the label 201, the patient 10, 11 oranother authorized party could visit the website identified by theaddress 203, and after entering the identifier 201 and the password 202,access the website EMRs, as further described below with reference toFIGURE X.

To simplify and accelerate accessing the website, the label can furtherinclude a barcode 204 that has encoded the identifier 201, the password202, and the website address 203. In one embodiment, the barcode 204 canbe a QR code, though other kinds of barcodes are possible. Afterscanning the barcode with a device that includes appropriate barcoderecognition software, such as a mobile phone or a separate scannerconnected to another computing device, the device with would enter theidentifier 201 and the password 202 into the website identified by theaddress 203 and present to the patient the webpage that includes thepatient's medical records.

The identifier 201 and the password 202 are also included with the datacollected by the monitor 12. During use, the electrode patch 15 is firstadhered to the skin along the sternal midline 16 (or immediately toeither side of the sternum 13). A monitor recorder 14 is then snappedinto place on the electrode patch 15 to initiate ECG monitoring. FIG. 5is a perspective view showing an extended wear electrode patch 15 with amonitor recorder 14 in accordance with one embodiment inserted. The bodyof the electrode patch 15 is preferably constructed using a flexiblebacking 220 formed as an elongated strip 221 of wrap knit or similarstretchable material with a narrow longitudinal mid-section 223 evenlytapering inward from both sides. A pair of cut-outs 222 between thedistal and proximal ends of the electrode patch 15 create a narrowlongitudinal midsection 223 or “isthmus” and defines an elongated“hourglass”-like shape, when viewed from above. The upper part of the“hourglass” is sized to allow an electrically non-conductive receptacle225, sits on top of the outward-facing surface of the electrode patch15, to be affixed to the electrode patch 15 with an ECG electrode placedunderneath on the patient-facing underside, or contact, surface of theelectrode patch 15; the upper part of the “hourglass” has a longer andwider profile (but still rounded and tapered to fit comfortably betweenthe breasts) than the lower part of the “hourglass,” which is sizedprimarily to allow just the placement of an ECG electrode of appropriateshape and surface area to record the P-wave and the QRS signalssufficiently given the inter-electrode spacing.

The electrode patch 15 incorporates features that significantly improvewearability, performance, and patient comfort throughout an extendedmonitoring period. During wear, the electrode patch 15 is susceptible topushing, pulling, and torqueing movements, including compressional andtorsional forces when the patient bends forward, and tensile andtorsional forces when the patient leans backwards. To counter thesestress forces, the electrode patch 15 incorporates strain and crimpreliefs, such as described in commonly-assigned U.S. Patent ApplicationPublication No. 2015/0087948, the disclosure of which is incorporated byreference. In addition, the cut-outs 222 and longitudinal midsection 223help minimize interference with and discomfort to breast tissue,particularly in women (and gynecomastic men). The cut-outs 222 andlongitudinal midsection 223 further allow better conformity of theelectrode patch 15 to sternal bowing and to the narrow isthmus of flatskin that can occur along the bottom of the intermammary cleft betweenthe breasts, especially in buxom women. The cut-outs 222 andlongitudinal midsection 223 help the electrode patch 15 fit nicelybetween a pair of female breasts in the intermammary cleft Still othershapes, cut-outs and conformities to the electrode patch 15 arepossible.

The monitor recorder 14 removably and reusably snaps into anelectrically non-conductive receptacle 225 during use. The monitorrecorder 14 contains electronic circuitry for recording and storing thepatient's electrocardiography as sensed via a pair of ECG electrodesprovided on the electrode patch 15, such as described incommonly-assigned U.S. Patent Application Publication No. 2015/0087949,the disclosure which is incorporated by reference. The non-conductivereceptacle 225 is provided on the top surface of the flexible backing220 with a retention catch 226 and tension clip 227 molded into thenon-conductive receptacle 225 to conformably receive and securely holdthe monitor recorder 14 in place.

The monitor recorder 14 includes a sealed housing that snaps into placein the non-conductive receptacle 225. FIG. 6 is a perspective viewshowing the monitor recorder 14 of FIG. 5. The sealed housing 250 of themonitor recorder 14 intentionally has a rounded isoscelestrapezoidal-like shape 252, when viewed from above, such as described incommonly-assigned U.S. Design Pat. No. D717,955, issued Nov. 18, 2014,the disclosure of which is incorporated by reference. In addition, alabel, barcode, QR code, or other visible or electronic indicia, such asthe identifier 201, is printed on the outside of, applied to the outsideof, or integrated into the sealed housing 250 to uniquely identify themonitor recorder 14 and can include a serial number, manufacturing lotnumber, date of manufacture, and so forth. The edges 251 along the topand bottom surfaces are rounded for patient comfort. The sealed housing250 is approximately 47 mm long, 23 mm wide at the widest point, and 7mm high, excluding a patient-operable tactile-feedback button 255. Thesealed housing 250 can be molded out of polycarbonate, ABS, or an alloyof those two materials. The button 255 is waterproof and the button'stop outer surface is molded silicon rubber or similar soft pliablematerial. A retention detent 253 and tension detent 254 are molded alongthe edges of the top surface of the housing 250 to respectively engagethe retention catch 226 and the tension clip 227 molded intonon-conductive receptacle 225. Other shapes, features, and conformitiesof the sealed housing 250 are possible.

As mentioned above, the electrode patch 15 is intended to be disposable.The monitor recorder 14, however, is reusable and can be transferred tosuccessive electrode patches 15 to ensure continuity of monitoring. Theplacement of the wearable monitor 12 in a location at the sternalmidline 16 (or immediately to either side of the sternum 13) benefitslong-term extended wear by removing the requirement that ECG electrodesbe continually placed in the same spots on the skin throughout themonitoring period. Instead, the patient is free to place an electrodepatch 15 anywhere within the general region of the sternum 13.

As a result, at any point during ECG monitoring, the patient's skin isable to recover from the wearing of an electrode patch 15, whichincreases patient comfort and satisfaction, while the monitor recorder14 ensures ECG monitoring continuity with minimal effort. A monitorrecorder 14 is merely unsnapped from a worn out electrode patch 15, theworn out electrode patch 15 is removed from the skin, a new electrodepatch 15 is adhered to the skin, possibly in a new spot immediatelyadjacent to the earlier location, and the same monitor recorder 14 issnapped into the new electrode patch 15 to reinitiate and continue theECG monitoring.

During use, the electrode patch 15 is first adhered to the skin in thesternal region. FIG. 7 is a perspective view showing the extended wearelectrode patch 15 of FIG. 5 without a monitor recorder 14 inserted. Aflexible circuit 232 is adhered to each end of the flexible backing 20.A distal circuit trace 233 and a proximal circuit trace (not shown)electrically couple ECG electrodes (not shown) to a pair of electricalpads 234. The electrical pads 234 are provided within amoisture-resistant seal 235 formed on the bottom surface of thenon-conductive receptacle 225. When the monitor recorder 14 is securelyreceived into the non-conductive receptacle 225, that is, snapped intoplace, the electrical pads 234 interface to electrical contacts (notshown) protruding from the bottom surface of the monitor recorder 14,and the moisture-resistant seal 235 enables the monitor recorder 14 tobe worn at all times, even during bathing or other activities that couldexpose the monitor recorder 14 to moisture.

In addition, a battery compartment 236 is formed on the bottom surfaceof the non-conductive receptacle 225, and a pair of battery leads (notshown) electrically interface the battery to another pair of theelectrical pads 234. The battery contained within the batterycompartment 235 can be replaceable, rechargeable or disposable.

The monitor recorder 14 draws power externally from the battery providedin the non-conductive receptacle 225, thereby uniquely obviating theneed for the monitor recorder 14 to carry a dedicated power source. FIG.8 is a bottom plan view of the monitor recorder 14 of FIG. 5. A cavity258 is formed on the bottom surface of the sealed housing 250 toaccommodate the upward projection of the battery compartment 236 fromthe bottom surface of the non-conductive receptacle 225, when themonitor recorder 14 is secured in place on the non-conductive receptacle225. A set of electrical contacts 256 protrude from the bottom surfaceof the sealed housing 250 and are arranged in alignment with theelectrical pads 234 provided on the bottom surface of the non-conductivereceptacle 225 to establish electrical connections between the electrodepatch 15 and the monitor recorder 14. In addition, a seal coupling 257circumferentially surrounds the set of electrical contacts 256 andsecurely mates with the moisture-resistant seal 235 formed on the bottomsurface of the non-conductive receptacle 225.

The placement of the flexible backing 220 on the sternal midline 16 (orimmediately to either side of the sternum 13) also helps to minimize theside-to-side movement of the wearable monitor 12 in the left- andright-handed directions during wear. To counter the dislodgment of theflexible backing 220 due to compressional and torsional forces, a layerof non-irritating adhesive, such as hydrocolloid, is provided at leastpartially on the underside, or contact, surface of the flexible backing20, but only on the distal end 230 and the proximal end 231. As aresult, the underside, or contact surface of the longitudinal midsection223 does not have an adhesive layer and remains free to move relative tothe skin. Thus, the longitudinal midsection 223 forms a crimp reliefthat respectively facilitates compression and twisting of the flexiblebacking 220 in response to compressional and torsional forces. Otherforms of flexible backing crimp reliefs are possible.

Unlike the flexible backing 20, the flexible circuit 232 is only able tobend and cannot stretch in a planar direction. The flexible circuit 232can be provided either above or below the flexible backing 20. FIG. 9 isa top view showing the flexible circuit 232 of the extended wearelectrode patch 15 of FIG. 5 when mounted above the flexible backing 20.A distal ECG electrode 238 and proximal ECG electrode 239 arerespectively coupled to the distal and proximal ends of the flexiblecircuit 232. A strain relief 240 is defined in the flexible circuit 232at a location that is partially underneath the battery compartment 236when the flexible circuit 232 is affixed to the flexible backing 20. Thestrain relief 240 is laterally extendable to counter dislodgment of theECG electrodes 238, 239 due to tensile and torsional forces. A pair ofstrain relief cutouts 241 partially extend transversely from eachopposite side of the flexible circuit 232 and continue longitudinallytowards each other to define in ‘S’-shaped pattern, when viewed fromabove. The strain relief respectively facilitates longitudinal extensionand twisting of the flexible circuit 232 in response to tensile andtorsional forces. Other forms of circuit board strain relief arepossible. Other forms of the patch 15 are also possible. For example, ina further embodiment, the distal and proximal circuit traces arereplaced with interlaced or sewn-in flexible wires, as further describedin commonly-assigned U.S. Patent Application Publication No.2015/0087951, the disclosure of which is incorporated by reference.

ECG monitoring and other functions performed by the monitor recorder 14are provided through a micro controlled architecture. FIG. 10 is afunctional block diagram showing the component architecture of thecircuitry 260 of the monitor recorder 14 of FIG. 5. The circuitry 260 isexternally powered through a battery provided in the non-conductivereceptacle 225 (shown in FIG. 6). Both power and raw ECG signals, whichoriginate in the pair of ECG electrodes 238, 239 (shown in FIG. 9) onthe distal and proximal ends of the electrode patch 15, are receivedthrough an external connector 265 that mates with a correspondingphysical connector on the electrode patch 15. The external connector 265includes the set of electrical contacts 256 that protrude from thebottom surface of the sealed housing 250 and which physically andelectrically interface with the set of pads 234 provided on the bottomsurface of the non-conductive receptacle 225. The external connectorincludes electrical contacts 256 for data download, microcontrollercommunications, power, analog inputs, and a peripheral expansion port.The arrangement of the pins on the electrical connector 265 of themonitor recorder 14 and the device into which the monitor recorder 14 isattached, whether an electrode patch 15 or download station (not shown),follow the same electrical pin assignment convention to facilitateinteroperability. The external connector 265 also serves as a physicalinterface to a download station that permits the retrieval of stored ECGmonitoring data, communication with the monitor recorder 14, andperformance of other functions.

Operation of the circuitry 260 of the monitor recorder 14 is managed bya microcontroller 261. The microcontroller 261 includes a program memoryunit containing internal flash memory that is readable and writeable.The internal flash memory can also be programmed externally. Themicrocontroller 261 draws power externally from the battery provided onthe electrode patch 15 via a pair of the electrical contacts 256. Themicrocontroller 261 connects to the ECG front end circuit 263 thatmeasures raw cutaneous electrical signals and generates an analog ECGsignal representative of the electrical activity of the patient's heartover time.

The microcontroller 261 operates under modular micro program control asspecified in firmware, and the program control includes processing ofthe analog ECG signal output by the ECG front end circuit 263. FIG. 11is a functional block diagram showing the signal processingfunctionality 170 of the microcontroller 261 in accordance with oneembodiment. The microcontroller 261 operates under modular micro programcontrol as specified in firmware 172. The firmware modules 172 includehigh and low pass filtering 173, and compression 174. Other modules arepossible. The microcontroller 261 has a built-in ADC, although ADCfunctionality could also be provided in the firmware 172.

The ECG front end circuit 263 first outputs an analog ECG signal, whichthe ADC 171 acquires, samples and converts into an uncompressed digitalrepresentation. The microcontroller 261 includes one or more firmwaremodules 173 that perform filtering. In one embodiment, a high passsmoothing filter is used for the filtering; other filters andcombinations of high pass and low pass filters are possible in a furtherembodiment. Following filtering, the digital representation of thecardiac activation wave front amplitudes are compressed by a compressionmodule 174 before being written out to storage 175.

The circuitry 260 of the monitor recorder 14 also includes a flashmemory 262, which the microcontroller 261 uses for storing ECGmonitoring data and other physiology and information. The data is storedin the memory 262 together with the identifier 201 associated with thepatch 15 and the password 202, which are obtained from the patch 15 asfurther described below. The flash memory 262 also draws powerexternally from the battery provided on the electrode patch 15 via apair of the electrical contacts 256. Data is stored in a serial flashmemory circuit, which supports read, erase and program operations over acommunications bus. The flash memory 262 enables the microcontroller 261to store digitized ECG data. The communications bus further enables theflash memory 262 to be directly accessed externally over the externalconnector 265 when the monitor recorder 14 is interfaced to a downloadstation.

The circuitry 260 of the monitor recorder 14 further includes anactigraphy sensor 264 implemented as a 3-axis accelerometer. Theaccelerometer may be configured to generate interrupt signals to themicrocontroller 261 by independent initial wake up and free fall events,as well as by device position. In addition, the actigraphy provided bythe accelerometer can be used during post-monitoring analysis to correctthe orientation of the monitor recorder 14 if, for instance, the monitorrecorder 14 has been inadvertently installed upside down, that is, withthe monitor recorder 14 oriented on the electrode patch 15 towards thepatient's feet, as well as for other event occurrence analyses, such asdescribed in commonly-assigned U.S. Patent Application Publication No.2015/0087923, the disclosure of which is incorporated by reference.

The circuitry 260 of the monitor recorder 14 includes a wirelesstransceiver 269 that can provides wireless interfacing capabilities. Thewireless transceiver 269 also draws power externally from the batteryprovided on the electrode patch 15 via a pair of the electrical contacts256. The wireless transceiver 269 can be implemented using one or moreforms of wireless communications, including the IEEE 280 2.11 computercommunications standard, that is Wi-Fi; the 4G mobile phone mobilestandard; the Bluetooth® data exchange standard; or other wirelesscommunications or data exchange standards and protocols. For example,the wireless transceiver 69 can be implemented using the Bluetooth® 4.0standard, allowing to conserve power, or Bluetooth® 4.2 standards,allowing the transceiver 69 to have at least some capabilities of acellular phone, as further described in the commonly-assigned U.S.patent application entitled “Contact-Activated Extended WearElectrocardiography and Physiological Sensor Monitor Recorder,” Ser. No.14/656,615, filed Mar. 12, 2015, the disclosure of which is incorporatedby reference.

The microcontroller 261 includes an expansion port that also utilizesthe communications bus. External devices, separately drawing powerexternally from the battery provided on the electrode patch 15 or othersource, can interface to the microcontroller 261 over the expansion portin half duplex mode. For instance, an external physiology sensor can beprovided as part of the circuitry 260 of the monitor recorder 14, or canbe provided on the electrode patch 15 with communication with themicrocontroller 261 provided over one of the electrical contacts 256.The physiology sensor can include an SpO₂ sensor, blood pressure sensor,temperature sensor, respiratory rate sensor, glucose sensor, airflowsensor, volumetric pressure sensing, or other types of sensor ortelemetric input sources. For instance, the integration of an airflowsensor is described in commonly-assigned U.S. Pat. No. 9,364,155, issuedJun. 14, 2016, the disclosure which is incorporated by reference.

Finally, the circuitry 260 of the monitor recorder 14 includespatient-interfaceable components, including a tactile feedback button266, which a patient can press to mark events or to perform otherfunctions, and a buzzer 267, such as a speaker, magnetic resonator orpiezoelectric buzzer. The buzzer 267 can be used by the microcontroller261 to output feedback to a patient such as to confirm power up andinitiation of ECG monitoring. Still other components as part of thecircuitry 260 of the monitor recorder 14 are possible.

While the monitor recorder 14 operates under micro control, most of theelectrical components of the electrode patch 15 operate passively. FIG.12 is a functional block diagram showing the circuitry 270 of theextended wear electrode patch 15 of FIG. 4. The circuitry 270 of theelectrode patch 15 is electrically coupled with the circuitry 260 of themonitor recorder 14 through an external connector 274. The externalconnector 274 is terminated through the set of pads 234 provided on thebottom of the non-conductive receptacle 225, which electrically mate tocorresponding electrical contacts 256 protruding from the bottom surfaceof the sealed housing 250 to electrically interface the monitor recorder14 to the electrode patch 15.

The circuitry 270 of the electrode patch 15 performs three primaryfunctions. First, a battery 271 is provided in a battery compartmentformed on the bottom surface of the non-conductive receptacle 225. Thebattery 271 is electrically interfaced to the circuitry 260 of themonitor recorder 14 as a source of external power. The uniqueprovisioning of the battery 271 on the electrode patch 15 providesseveral advantages. First, the locating of the battery 271 physically onthe electrode patch 15 lowers the center of gravity of the overallwearable monitor 12 and thereby helps to minimize shear forces and theeffects of movements of the patient and clothing. Moreover, the housing250 of the monitor recorder 14 is sealed against moisture and providingpower externally avoids having to either periodically open the housing250 for the battery replacement, which also creates the potential formoisture intrusion and human error, or to recharge the battery, whichcan potentially take the monitor recorder 14 off line for hours at atime. In addition, the electrode patch 15 is intended to be disposable,while the monitor recorder 14 is a reusable component. Each time thatthe electrode patch 15 is replaced, a fresh battery is provided for theuse of the monitor recorder 14, which enhances ECG monitoringperformance quality and duration of use. Finally, the architecture ofthe monitor recorder 14 is open, in that other physiology sensors orcomponents can be added by virtue of the expansion port of themicrocontroller 261. Requiring those additional sensors or components todraw power from a source external to the monitor recorder 14 keeps powerconsiderations independent of the monitor recorder 14. Thus, a batteryof higher capacity could be introduced when needed to support theadditional sensors or components without effecting the monitor recorderscircuitry 260.

Second, the pair of ECG electrodes 238, 239 respectively provided on thedistal and proximal ends of the flexible circuit 232 are electricallycoupled to the set of pads 234 provided on the bottom of thenon-conductive receptacle 225 by way of their respective circuit traces233, 237. The signal ECG electrode 239 includes a protection circuit272, which is an inline resistor that protects the patient fromexcessive leakage current.

Last, the circuitry 270 of the electrode patch 15 includes acryptographic circuit 273 that stores an encoded password 202 foraccessing data collecting using this patch 15. The password 202 isencrypted using the secret key 203 to prevent an unauthorized party fromobtaining the password 202 once the patch 15 is discarded by thepatient. The password 202 is encrypted using a secret key of which themicro-controller 261 has a copy. Thus, only the micro-controller 261 caninterface with the cryptographic circuit 273 to obtain the password 202and decode the password 202 using the secret key, which can be stored inthe memory 262. The cryptographic circuit can further store theidentifier 201 associated with that patch and the identifier 201 canalso be retrieved by the micro-controller 261. In one embodiment, theidentifier 201 can be encrypted; in a further embodiment, the identifier201 can be unencrypted.

In a further embodiment, the cryptographic circuit 73 could be used toauthenticate an electrode patch 15 for use with a monitor recorder 14.The cryptographic circuit 273 includes a device capable of secureauthentication and validation. The cryptographic device 273 ensures thatonly genuine, non-expired, safe, and authenticated electrode patches 15are permitted to provide monitoring data to a monitor recorder 14, suchas described in commonly-assigned U.S. Patent Application PublicationNo. 2015/0087950, the disclosure which is incorporated by reference.

The ECG front end circuit 263 measures raw cutaneous electrical signalsusing a driven reference that effectively reduces common mode noise,power supply noise and system noise, which is critical to preserving thecharacteristics of low amplitude cardiac action potentials, especiallythose signals from the atria. FIG. 13 is a schematic diagram 280 showingthe ECG front end circuit 263 of the circuitry 260 of the monitorrecorder 14 of FIG. 9 in accordance with one embodiment. The ECG frontend circuit 263 senses body surface potentials through a signal lead(“S1”) and reference lead (“REF”) that are respectively connected to theECG electrodes of the electrode patch 15. Power is provided to the ECGfront end circuit 263 through a pair of DC power leads (“VCC” and“GND”). An analog ECG signal (“ECG”) representative of the electricalactivity of the patient's heart over time is output, which the microcontroller 11 converts to digital representation and filters, as furtherdescribed infra.

The ECG front end circuit 263 is organized into five stages, a passiveinput filter stage 281, a unity gain voltage follower stage 282, apassive high pass filtering stage 283, a voltage amplification andactive filtering stage 284, and an anti-aliasing passive filter stage285, plus a reference generator. Each of these stages and the referencegenerator will now be described.

The passive input filter stage 281 includes the parasitic impedance ofthe ECG electrodes 238, 239 (shown in FIG. 12), the protection resistorthat is included as part of the protection circuit 272 of the ECGelectrode 239 (shown in FIG. 12), an AC coupling capacitor 287, atermination resistor 288, and filter capacitor 289. This stage passivelyshifts the frequency response poles downward there is a high electrodeimpedance from the patient on the signal lead S1 and reference lead REF,which reduces high frequency noise.

The unity gain voltage follower stage 282 provides a unity voltage gainthat allows current amplification by an Operational Amplifier (“Op Amp”)290. In this stage, the voltage stays the same as the input, but morecurrent is available to feed additional stages. This configurationallows a very high input impedance, so as not to disrupt the bodysurface potentials or the filtering effect of the previous stage.

The passive high pass filtering stage 283 is a high pass filter thatremoves baseline wander and any offset generated from the previousstage. Adding an AC coupling capacitor 291 after the Op Amp 290 allowsthe use of lower cost components, while increasing signal fidelity.

The voltage amplification and active filtering stage 284 amplifies thevoltage of the input signal through Op Amp 291, while applying a lowpass filter. The DC bias of the input signal is automatically centeredin the highest performance input region of the Op Amp 291 because of theAC coupling capacitor 291.

The anti-aliasing passive filter stage 285 provides an anti-aliasing lowpass filter. When the microcontroller 261 acquires a sample of theanalog input signal, a disruption in the signal occurs as a sample andhold capacitor that is internal to the microcontroller 261 is charged tosupply signal for acquisition.

The reference generator in subcircuit 286 drives a driven referencecontaining power supply noise and system noise to the reference leadREF. A coupling capacitor 287 is included on the signal lead S1 and apair of resistors 293 a, 293 b inject system noise into the referencelead REF. The reference generator is connected directly to the patient,thereby avoiding the thermal noise of the protection resistor that isincluded as part of the protection circuit 272.

In contrast, conventional ECG lead configurations try to balance signaland reference lead connections. The conventional approach suffers fromthe introduction of differential thermal noise, lower input common moderejection, increased power supply noise, increased system noise, anddifferential voltages between the patient reference and the referenceused on the device that can obscure, at times, extremely, low amplitudebody surface potentials.

Here, the parasitic impedance of the ECG electrodes 238, 239, theprotection resistor that is included as part of the protection circuit272 and the coupling capacitor 287 allow the reference lead REF to beconnected directly to the skin's surface without any further components.As a result, the differential thermal noise problem caused by pairingprotection resistors to signal and reference leads, as used inconventional approaches, is avoided.

In a further embodiment, the circuitry 270 of the electrode patch 15includes a wireless transceiver 275, in lieu the including of thewireless transceiver 269 in the circuitry 260 of the monitor recorder14, which interfaces with the microcontroller 261 over themicrocontroller's expansion port via the external connector 274.Similarly to the wireless transceiver 269, the wireless transceiver 275can be implemented using a standard that allows to conserve batterypower, such as the Bluetooth® 4.0 standard, though other standards arepossible. Further, similarly to the wireless transceiver 269, thewireless transceiver 275 can be implemented using a standard that allowsthe transceiver 275 to act have cellular phone capabilities, such as theBluetooth® 4.2 standard.

The monitor recorder 14 continuously monitors the patient's heart rateand physiology. FIG. 14 is a flow diagram showing a monitorrecorder-implemented method 100 for monitoring ECG data for use in themonitor recorder 14 of FIG. 4. Initially, upon being connected to theset of pads 234 provided with the non-conductive receptacle 225 when themonitor recorder 14 is snapped into place, the microcontroller 261executes a power up sequence (step 101). During the power up sequence,the voltage of the battery 271 is checked, the state of the flash memory262 is confirmed, both in terms of operability check and availablecapacity, and microcontroller operation is diagnostically confirmed. Ina further embodiment, an authentication procedure between themicrocontroller 261 and the electrode patch 15 are also performed.

The micro-controller 61 retrieves and, as necessary, decodes thepassword 202 and the identifier 201 associated with the electrode patch15 (step 102). Subsequent physiological data obtained using the patch 15is stored in the memory 262 with the password 202 and the identifier inplaintext, unencrypted, form.

Following satisfactory completion of the power up sequence and thedecoding, an iterative processing loop (steps 103-112) is continuallyexecuted by the microcontroller 261. During each iteration (step 103) ofthe processing loop, the ECG front end 263 (shown in FIGS. 9 and 15)continually senses the cutaneous ECG electrical signals (step 104) viathe ECG electrodes 238, 239 and is optimized to maintain the integrityof the P-wave. A sample of the ECG signal is read (step 105) by themicrocontroller 261 by sampling the analog ECG signal output front end263. FIG. 15 is a graph showing, by way of example, a typical ECGwaveform 190. The x-axis represents time in approximate units of tenthsof a second. The y-axis represents cutaneous electrical signal strengthin approximate units of millivolts. The P-wave 191 has a smooth,normally upward, that is, positive, waveform that indicates atrialdepolarization. The QRS complex usually begins with the downwarddeflection of a Q wave 192, followed by a larger upward deflection of anR-wave 193, and terminated with a downward waveform of the S wave 194,collectively representative of ventricular depolarization. The T wave195 is normally a modest upward waveform, representative of ventriculardepolarization, while the U wave 196, often not directly observable,indicates the recovery period of the Purkinje conduction fibers.

Sampling of the R-to-R interval enables heart rate informationderivation. For instance, the R-to-R interval represents the ventricularrate and rhythm, while the P-to-P interval represents the atrial rateand rhythm. Importantly, the PR interval is indicative ofatrioventricular (AV) conduction time and abnormalities in the PRinterval can reveal underlying heart disorders, thus representinganother reason why the P-wave quality achievable by the extended wearambulatory electrocardiography and physiological sensor monitordescribed herein is medically unique and important. The long-termobservation of these ECG indicia, as provided through extended wear ofthe wearable monitor 12, provides valuable insights to the patient'scardiac function and overall well-being.

Returning to FIG. 14, in a further embodiment, the monitor recorder 14also continuously receives data from wearable physiology monitors oractivity sensor, such as described in commonly-assigned U.S. PatentApplication Publication No. 2015/0088007, the disclosure of which isincorporated by reference. Optionally, If wireless data is available(step 106), a sample of the wireless is read (step 107) by themicrocontroller 61. If wireless data is not available (step 106), themethod 100 moves to step 108.

Each sampled ECG signal, in quantized and digitized form, is temporarilystaged in buffer (step 108), pending compression preparatory to storagein the flash memory 262 (step 109). If wireless data sample was read instep 106, the wireless data sample, in quantized and digitized form, istemporarily staged in the buffer (step 108), pending compressionpreparatory to storage in the flash memory 62 (step 109). Followingcompression, the compressed ECG digitized sample, and if present, thewireless data sample, is again buffered (step 110), then written to theflash memory 262 (step 111) using the communications bus. Processingcontinues (step 112), so long as the monitoring recorder 14 remainsconnected to the electrode patch 15 (and storage space remains availablein the flash memory 262), after which the processing loop is exited andexecution terminates. Still other operations and steps are possible. Ina further embodiment, the reading and storage of the wireless data takesplace, in a conceptually-separate execution thread, such as described incommonly-assigned U.S. Patent Application Publication No. 2015/0088007,to Bardy et al., the disclosure of which is incorporated by reference.

Once ECG data is collected by the monitor 12, the data can undergovarious kinds of processing. In particular, the ECG data can undergoadditional filtering to further remove noise. An ECG includes multiplewaveforms reflecting multiple contractions of a patient's heart. ECGsignals include low amplitude voltages in the presence of high offsetsand noise, which requires the signals to be amplified and filtered priorto being displayed for interpretation. In an unfiltered ECG, some of thefeatures may not be apparent, particularly if their shapes have beencorrupted by noise. For example, the P-wave morphology, presence orabsence, timing, and size can be indicative of a variety of cardiacconditions. An abnormally large P-wave can be indicative of atrialhypertrophy, an abnormally wide P-wave can be indicative of anintra-atrial block, and atrial flutter may cause the P-waves to adopt a“saw-tooth” or negative shape. Absent or not-easily discernible P-wavescan be indicative of atrial fibrillation, while discrete P-waves thatvary from beat-to-beat with at least three different morphologies, canbe indicative of multifocal atrial tachycardia. A dissociation betweenthe timing of the P-wave and the QRS complex can indicate ventriculartachycardia. Other associations between the P-wave and cardiacconditions exist. Identifying presence, timing and morphology or theP-wave is critical to arrhythmia diagnosis.

Noise in an ECG or inadequate signal clarity is a major problematic forcardiologists when caring for patients with possible cardiacarrhythmias. FIG. 16 is a graph showing, by way of example, an ECGwaveform 20 of a patient with atrial flutter for a single cardiac cycle,where the ECG waveform 20 has been corrupted by power line noise. In theUnited States, power line noise has a frequency of 60 Hz with a highamplitude. The wall outlets in an examination room invariably surround apatient and create an electrical field that causes power line noise tobe coupled into the ECG. Here the patient's ECG lacks a clearly definedP-wave, with the signal noise obscuring the “saw-tooth” P-wave shapeseen in the underlying atrial flutter. As a result, the diagnosis ismissed.

Classical ways to reduce power line noise are to make physical changesto the circuit design of ECG equipment. For instance, power line noisecan be reduced by isolating front-end ground electronics from thedigital components of the machine, and using shielded cables to acquireECG signals driven with a common voltage to reduce noise from beingcoupled from proximal power lines. However, some degree of power linenoise will always be present due to the power draw of the ECG machineitself. Power line noise is more predictable and more readily lendsitself to classical noise-reduction techniques, as described above.

Other types of noise, such as those associated with muscle activity,often the main source of ECG noise, including baseline wander, is bestdiminished with a more patient-specific and dynamic method of noisereduction involving the appropriate application of digital noisefilters.

Digital filters are inherently flexible. Changing the characteristics ofa digital filter merely involves changing the program code or filtercoefficients. They also do not require physical reconstruction of theECG system, and thus tend to be low cost and highly compatible withexisting ECG equipment. Noise present in an ECG of one patient can bedifferent from noise present in an ECG of another patient, and theflexibility provided by the digital filters helps to clarify eachindividual ECG and provide for patient-specific ECG signal processing.In addition, digital filters are immune to the effects of wear anddegradation that all hardware experiences.

ECG noise can be effectively reduced by allowing a user to pickparticular portions of an ECG for application of a filter and allowingthe user to compare results of applications of different filters to theselected portions. This is critical when seeking to record the moredifficult-to-see P-wave compared to the high voltage high frequencycontent of the QRS wave. FIG. 17 is a diagram showing a screen shotgenerated by an application 30 for interactive processing of ECG data inaccordance with one embodiment. The application 30 can be a downloadableapplication executed on a user device 31. While the user device 31 isshown as a tablet computer with reference to FIG. 4, other kinds of userdevices 31, such as mobile phones, desktop computer, laptop computers,portable media players are possible; still other types of user devices31 are possible. The user device 31 can include componentsconventionally found in general purpose programmable computing devices,such as a central processing unit, memory, input/output ports, networkinterfaces, and non-volatile storage, although other components arepossible. The central processing unit can implement computer-executablecode, including digital ECG filters, which can be implemented asmodules. The modules can be implemented as a computer program orprocedure written as source code in a conventional programming languageand presented for execution by the central processing unit as object orbyte code. Alternatively, the modules could also be implemented inhardware, either as integrated circuitry or burned into read-only memorycomponents, and the user device starts acting a specialized computer.For instance, when the modules are implemented as hardware, thatparticular hardware is specialized to perform the ECG trace analysisdescribed below and other computers cannot be used. Additionally, whenthe modules are burned into read-only memory components, the user device31 storing the read-only memory becomes specialized to perform the ECGprocessing described below that other computers cannot. The variousimplementations of the source code and object and byte codes can be heldon a computer-readable storage medium, such as a floppy disk, harddrive, digital video disk (DVD), random access memory (RAM), read-onlymemory (ROM) and similar storage mediums. Other types of modules andmodule functions are possible, as well as other physical hardwarecomponents.

The application 30 receives results of an ECG monitoring, which caninclude an ECG 32, including in a printed form. The ECG 32 can bereceived at once, such as upon completion of monitoring, or in portions,as the monitoring progresses. In addition to the ECG 32, the application30 the identifier 201 associated with the patch 15 used for datacollection.

A user may select a portion 34 of the displayed ECG 32 for applicationof one or more digital filters, such as by clicking on the portion orhighlighting the portion with a mouse. The selected portion 34 can bezoomed and displayed in a separate area 35 of the application screen. Bylooking at the selection in the area 35, the user can decide whatfilters to apply to the selection 34.

Application of filters to an ECG can result in a loss of clinicalinformation present in the ECG waves. Only a limited number of filterscan be applied before such clinical information is lost due to thefilters introducing distortions into some part of the ECG signals. Forexample, a high-pass filter, a filter whose purpose is to removelow-frequency noise, introduces distortions to the ST segment of ECG.The distortion arises from the combination of the frequencies of some ofthe noise overlapping with the spectra of useful ECG waves, with thenoise generally being stochastic; thus any attempt of removing thenoises after signal acquisition is typically accompanied by some degreeof signal degradation. An excessive number or an incorrect set ofapplied filters can remove useful diagnostic features from the ECGwaveform, leading to false diagnostic statements. By selecting a portion34 of the ECG and, applying filters only to that portion, the rest ofthe ECG 32 is maintained intact and unfiltered.

The user may filter the selection 34 using a list of ECG digital noisefilters provided by application in filter selection menus 36, 38. Byselecting the filters in different menus 36, 38, the user can selectdifferent sets of filters for filtering the ECG 32. Each of the digitalfilters is a mathematical algorithm that is applied to digital ECGsignals to output a set of filtered signals that differs from the set ofthe ECG signals to which that filter is initially applied. The filterscan be stored in the memory of the user device 31. Such filters caninclude a low-pass filter, which attenuates noise with a frequencyhigher than a cut-off frequency; a high-pass filter, which attenuatessignals with frequencies lower than the cut-off frequency; a notchfilter, which passes all frequencies except those in a stop-bandcentered on a center frequency; a phase correction filter, whichcorrects a phase of an ECG wave following earlier digital processing;and an adaptive filter, which obtains the frequency of the noisepresent, such as based on patient input or by calculating the noise, andminimizes the identified noise. Other types of filters are possible.

The user can customize the filter selection menus 36, 38. For instance,the user can change the order in which the filters are displayed in theselection menus 36, 38, such as by dragging and dropping the filterswith a mouse. Thus, if the user uses particular filters more often thanother filters, the more used filters can be brought to the top of themenus 36, 38. Further, the order of the filters in the filter selectionmenu 36 can be different from the order in the menu 38.

Also, the user can select the displayed filters, such as by clicking ona name of one of the filters, and change one or more parameters of theselected filter. For example, if the selected filter is a high-passfilter, the user can enter a cut-off frequency used for the filter.Other parameters can also be changed. The desired parameters can bechanged in a separate window of the application 32 that appears upon thefilter being selected, though other ways for the user to change theparameters are possible. Still other ways to customize the filterselection menus are possible.

The user may apply different filters or combinations of filters to theselection 34, and see the results of applications of different filtersside-by-side in the areas 37 and 39. For example, the user may select anotch filter to be applied to the selection 34, and see the results ofthe application of the filter, a filtered ECG of the selection, in thearea 37. While the application of the notch filter results in a clearershape of the selection 34, including that of the P-wave, if the user isstill not satisfied with the result, the user can choose in the filterselection menu 38 to choose to apply a different set of filters,choosing the notch filter in combination with the low-pass filter tofurther remove the noise from the selection 34, with the results of theapplication of the filters being displayed in the area 39. The user cancompare the application of different selected filters side-by-side anddecide whether any of the applied filters or combinations of filtersproduce a satisfactory result or whether applications of other filtersare necessary. The results of application of different filters to theselection 34 are displayed to the user immediately upon becomingavailable, allowing the user to explore different filter setpossibilities in real-time and reducing the time necessary to find themost appropriate filter set.

If the user is satisfied with a filtered ECG of the selection in thearea 37 or 39, the user can replace the selection 34 of the ECG 32 withthe filtered ECG of the selection in area 37 or 39, such as by draggingthe selection in the area 37, 39 to the displayed ECG 32 or pressing abutton on the screen of the application 31 (not shown).

While two sets of filter selection menus 36, 38 and areas with theresults of filter application 38, 39 are shown in the screen of theapplication, in a further embodiment, other numbers of filter menus andareas showing results of the filtering using the selected filters arepossible.

As further described with reference to FIGS. 17 and 1, the application30 can make a recommendation (not shown) of one or more filters to beapplied to the selection 34. The recommendation is created byidentifying a frequency of a noise recurring in the selection 34(“recursive noise”), such as presence of 60 Hz power line noise, basedon one or more of user input or mathematical estimation of the noisefrequency, and recommending the frequency based on the noise. Forexample, if the recursive noise includes power line noise, a notchfilter or a low-pass filter can be recommended to remove the noise. Therecommendation can be presented in different ways, such as presentingthe recommendation in a separate field on the screen of the application30 or by highlighting the filters presented in the menus 36, 38.

In a further embodiment, in addition to providing a filteringrecommendation, the application 30 can automatically apply one or morefilters to an ECG prior to presenting the ECG to the user, saving theuser the labor of filtering noise that can be automatically identifiedand removed. The application 30 can identify the presence of noise in anECG received from an ECG monitor or from another source, automaticallyapply a filter or a combination of filters to digitized signals forportions of the ECG with the noise, and generate the ECG 32 that isdisplayed to the user based on digitized signals that have been filteredand any digitized signals that did not include the noise. For example,if the application 30 identifies baseline wander corrupting a receivedECG, which can be identified using techniques such as measuringdeviation of signals from the baseline in a random fashion within setfrequency domains, the application 30 can automatically apply a filteror a set of filters to digitized signals for portions of the ECG withthe baseline wander, and generate the ECG 32 displayed to the user basedon digitized signals that have been filtered and signals that have notbeen corrupted by the baseline wander. The filters to be applied can bedetermined via testing, such by as applying different filters, such asvarious high-pass filters, or combinations of filters to the digitizedsignals and identifying the filters or combinations of filters thatresult in the greatest reduction of the baseline wander. In a furtherembodiment, a preset filter or combination of filters can be used toautomatically reduce or remove the baseline wander. In a still furtherembodiment, the application 30 can also test effect of changingparameters of the filters on the removal of the noise, and choose themost appropriate parameters for the filters used. Other kinds ofautomated application of filters are possible.

Allowing a user to choose and selectively apply filters to selectedportions of an ECG facilitates obtaining an ECG that includesdiscernible diagnostic information and can be used for patientdiagnosis. FIG. 8 is a flow diagram showing a method 60 for interactiveprocessing of ECG data in accordance with one embodiment. Initially, anECG 32 that is a result of electrocardiographic monitoring of a patientis obtained by the application 30 executed on the user device 31 (step61). The ECG 32 can be obtained from an ECG monitor or from othersources, as described above, and can be obtained upon a completion ofthe monitoring, or continuously received in real-time as monitoringprogresses. In a still further embodiment, both the ECG 32 and thedigitized ECG signals corresponding to the ECG 32 can be obtained.

Optionally, if the application 30 identifies presence of noise, such asbaseline wander, in the ECG received from a monitor or another source,the application 30 can automatically apply one or more filters todigitized signals corresponding to portions of the obtained ECG that hasthe noise, with the ECG 32 that is subsequently displayed to the userbeing generated based on the filtered digitized signals and signals forportions of the ECG that did not include the baseline wander, as furtherdescribed above with reference to FIG. 6 (step 62).

The ECG 32, after having been optionally automatically filtered, isdisplayed on a display screen of the user device 31 (step 63). If theECG 32 is received over a period of time, such as when the ECG is aresult of an ongoing electrocardiographic monitoring, portions of theECG can be updated in real-time as they are being received, with thedisplayed ECG being updated as more results of the monitoring becomeavailable. If the ECG 32 is a result of an already completed monitoring,all portions of the ECG can be displayed at the same time.

A user selection 34 of a portion of the ECG is received, such as via theuser touching the portion on the touch-screen display of the user device31, entering the selection from a keyboard, or using a mouse (step 64).Digitized ECG signals corresponding to the selected portion 34 of theECG are obtained by the application 30 (step 65). If the digitizedsignals for the ECG 32 were received with the ECG 32, the signalscorresponding to the selection 34 can be identified among the receivedsignals. If no digitized ECG signals have been received, the application30 can reconstruct the digitized signals from the selection 34. Otherways to obtain the digitized signals are possible.

Optionally, the selection is zoomed and the zoomed selection 35 isdisplayed to the user by the application (step 66). A list, such as inthe selection menus 36, 38, of a plurality of digital ECG filters forfiltering the selection is displayed to the user, with the user beingable to select one or more sets of the filters for filtering theselection (step 67). Optionally, a filter recommended for processing theselection 34 is determined and displayed to the user, as furtherdescribed with reference to FIG. 9 (step 68). A user selection of one ormore sets of the filters is received by the application 30, with each ofthe filter sets including at least one of the filters displayed (step69). The application 30 applies each of the sets of the selected filtersto the digitized ECG signals for the selection (step 70), generatesfiltered ECG for the selection based on the digital signals filtered byeach of the sets, and displays the filtered ECG for the selection onportions 37, 39 of the display screen of the user device 31 (step 71).The filtered ECGs can be displayed visually proximate to each other,allowing comparison of results of filtering side-by-side, and thusenabling the user to decide which of the results is more useful, whetherone of the results satisfies the user's needs, or whether a stilldifferent set of filters needs to be applied. Optionally, upon receivinga user selection of one of the filtered ECGs for the selection, theapplication 30 can replace the selected portion 34 of the ECG 32 withthe selected filtered ECG (step 72), ending the method 60.

Recommending an ECG filter to the user can save the user time andsimplify ECG interpretation for the user. FIG. 19 is a flow diagramshowing a routine 80 for recommending an ECG filter to a user for use inthe method 60 of FIG. 18 in accordance with one embodiment. First, afrequency of a recursive noise present in the ECG selection isidentified (step 81). Second, one or more digital filters are selectedbased on the noise frequency (step 82). For example, if the selectionincludes high-frequency recursive noise, a low-pass filter can be chosenfor the recommendation. Lastly, the selected filter is recommended to auser, terminating the routine 80 (step 83).

The data obtained from the monitor 12, and optionally, filtered usingthe application 30, can be securely retrieved, stored, and accessed bythe patient upon using the information on the label 200. FIG. 20 is afunctional block diagram showing a computer-implemented system 40 forsecure physiological data collection and processing in accordance withone embodiment.

The system 40 includes the monitor 12, which can offload data in anumber of ways. Prior to being used to perform physiological monitoring,the recorder 14 and the patch 15 can be programmed using a programmingwand 207. In particular, the wand 207 can generate the password 202 foran identifier 201 and load the identifier 201 and the password into thepatch 15. In one embodiment, the wand can generate the identifier 201;in a further embodiment, the identifier 201 can be preloaded into thepatch 15. The wand 207 also loads the secret key used to decode thepassword 202 into the monitor recorder 14. The wand 207 can interfacewith the recorder 14 and the patch 15 wirelessly, such as through thewireless transceivers 269 and 275. In a further embodiment, the wand 207can interface with the recorder 14 and the patch 15 through wiredconnections. The wand 207 can include a wireless transceiver and canwirelessly interface with the server 54. For example, after loading anidentifier 201 and the password 201 into the patch 15, the wand 207 canwirelessly send a report to the server 54 of what identifier 201 hasbeen used and the password 202 generated for that identifier 202. Theserver 54 can keep track of whether data for the identifier has beenreceived.

In one embodiment, the wand 207 can be used to program any number ofpatches 15 and recorders 14. In a further embodiment, the wand 207 canbe configured to need recalibration after a preset number of uses.

As mentioned above, one of the options for offloading data from themonitor 12 can offload data to a download station 44. The monitor 12 hasa set of electrical contacts (not shown) that enable the monitorrecorder 14 to physically interface to a set of terminals 45 on a pairedreceptacle 46 of the download station 44. In turn, the download station44 can execute a communications or offload program 47 (“Offload”) orsimilar program that interacts with the monitor recorder 14 via thephysical interface to retrieve the stored ECG monitoring data. Whenoffloading the data off the monitor recorder, the identifier 201 and thedecoded password 202 are included at the beginning of the stream of datathat the monitor recorder 12 transfers to the download station 44. Thedownload station 44 could be the user device 31 or another server, suchas server 54, personal computer, tablet or handheld computer, smartmobile device, or purpose-built device designed specific to the task ofinterfacing with a monitor 12. Still other forms of download station 44are possible. Also, as mentioned below, the data from the monitor 12 canbe offloaded wirelessly.

The download station 44 can include an array of filtering modules thatcan perform processing of collected data instead of or in addition tothe processing done using the application 30. For instance, a set ofphase distortion filtering tools 144 may be provided as shown in FIG.21. The digital signals are run through the software filters in areverse direction to remove phase distortion. For instance, a 45 Hertzhigh pass filter in firmware may have a matching reverse 45 Hertz highpass filter in software. Most of the phase distortion is corrected, thatis, canceled to eliminate noise at the set frequency, but data at otherfrequencies in the waveform remain unaltered. As well, bidirectionalimpulse infinite response (IIR) high pass filters and reverse direction(symmetric) IIR low pass filters can be provided. Data is run throughthese filters first in a forward direction, then in a reverse direction,which generates a square of the response and cancels out any phasedistortion. This type of signal processing is particularly helpful withimproving the display of the ST-segment by removing low frequency noise.

An automatic gain control (AGC) module 145 can also be provided toadjust the digital signals to a usable level based on peak or averagesignal level or other metric. AGC is particularly critical tosingle-lead ECG monitors, where physical factors, such as the tilt ofthe heart, can affect the electrical field generated. On three-leadHolter monitors, the leads are oriented in vertical, horizontal anddiagonal directions. As a result, the horizontal and diagonal leads maybe higher amplitude and ECG interpretation will be based on one or bothof the higher amplitude leads. In contrast, the electrocardiographymonitor 12 has only a single lead that is oriented in the verticaldirection, so variations in amplitude will be wider than available withmulti-lead monitors, which have alternate leads to fall back upon.

In addition, AGC may be necessary to maintain compatibility withexisting ECG interpretation software, which is typically calibrated formulti-lead ECG monitors for viewing signals over a narrow range ofamplitudes. Through the AGC module 145, the gain of signals recorded bythe monitor recorder 14 of the electrocardiography monitor 12 can beattenuated up (or down) to work with FDA-approved commercially availableECG interpretation.

AGC can be implemented in a fixed fashion that is uniformly applied toall signals in an ECG recording, adjusted as appropriate on arecording-by-recording basis. Typically, a fixed AGC value is calculatedbased on how an ECG recording is received to preserve the amplituderelationship between the signals. Alternatively, AGC can be varieddynamically throughout an ECG recording, where signals in differentsegments of an ECG recording are amplified up (or down) by differingamounts of gain.

Typically, the monitor recorder 14 will record a high resolution, lowfrequency signal for the P-wave segment. However, for some patients, theresult may still be a visually small signal. Although high resolution ispresent, the unaided eye will normally be unable to discern the P-wavesegment. Therefore, gaining the signal is critical to visually depictingP-wave detail. This technique works most efficaciously with a raw signalwith low noise and high resolution, as generated by the monitor recorder14. Automatic gain control applied to a high noise signal will onlyexacerbate noise content and be self-defeating.

Finally, the download station 44 can include filtering modulesspecifically intended to enhance P-wave content. For instance, a P-waveenhancement filter 146, which is a form of pre-emphasis filter, can beapplied to the signal to restore missing frequency content or to correctphase distortion. Still other filters and types of signal processing arepossible.

In addition to the processing described above, the download station 44can also convert retrieved data into a format suitable for use by thirdparty post-monitoring analysis software, such as the application 30, asfurther described below with reference to FIG. 22. If the downloadstation 44 is not the user device 31, the formatted data can then beretrieved from the download station 44 over a hard link 48 using acontrol program 49 (“Ctl”) or analogous application executing on apersonal computer 50 or other connectable computing device, via acommunications link (not shown), whether wired or wireless, or byphysical transfer of storage media (not shown). The personal computer 50or other connectable device may also execute middleware that convertsECG data and other information into a format suitable for use by athird-party post-monitoring processing program, such the application 30.Note that formatted data stored on the personal computer 50 would haveto be maintained and safeguarded in the same manner as electronicmedical records (EMRs) 51 in a secure database 52, as further discussedinfra. In a further embodiment, the download station 44 is able todirectly interface with other devices over a computer communicationsnetwork 53, which could be some combination of a local area network anda wide area network, including the Internet, over a wired or wirelessconnection. Still other forms of download station 44 are possible. Inaddition, the wearable monitor 12 can interoperate with other devices,as further described in detail in commonly-assigned U.S. PatentApplication Publication No. 2015/0087921, the disclosure of which isincorporated by reference. In addition, the wearable monitor 12 iscapable of interoperating wirelessly with mobile devices 132, includingso-called “smartphones,” and can use the mobile devices 132 to relaycollected data to other devices in the system 40, such as described incommonly-assigned U.S. Patent Application Publication No. 2015/0088007,the disclosure of which is incorporated by reference. Further, asmentioned above, the monitor 12 can include a wireless transceiver witha cellular phone capabilities, and in a further embodiment could connectdirectly to the network 53 and interact with other devices in the system40, such as the server 54, the download station 44, and the mobiledevice 132 using the network 53.

A client-server model could be used to employ a server 54 to remotelyinterface with the download station 44 over the network 53 and retrievethe formatted data or other information. The server 54 executes apatient management program 55 (“Mgt”) or similar application that storesthe retrieved formatted data and other information in the securedatabase 52 cataloged in that patient's EMRs 51. The application 30 canreceive the results of the monitoring from the server 54 if inpossession of the identifier 201 and password 202. In addition, thepatient management program 55 could manage a subscription service thatauthorizes a monitor recorder 12 to operate for a set period of time orunder pre-defined operational parameters.

In a further embodiment, the download station 44 could be used totransfer data from the monitor 12 to the server 54 without involvementof the network 53. For example, following a completion of themonitoring, the patient 11 can use an envelope 206 to mail the monitorto a processing center (not shown), where information is extracted fromthe monitor 12 using the download station 44 directly connected to theserver 54.

In a still further embodiment, the server 54 could receive the datacollected by the monitor 12 directly from the monitor 12 over a wirelessconnection.

Upon receiving the data collected by the monitor 12, which includes datasuch as ECG data and other physiological data, the server 54 identifiesthe password 202 and the identifier 201 in the data.

The patient management program 55, or other trusted application executedby the server 54, also maintains and safeguards the secure database 52to limit access to patient EMRs 51 to only authorized parties forappropriate medical or other uses, such as mandated by state or federallaw, such as under the HIPAA or per the European Union's Data ProtectionDirective. For example, a physician may seek to review and evaluate hispatient's ECG monitoring data, as securely stored in the secure database52. In particular, the database stores a log 58 of identifiers 201 ofthe patches 15 that have been issued and the passwords 202 that areassociated with the patches 15 with the identifiers. Once the serverreceives the data from the monitor 12, the server compares theidentifiers 201 and passwords 202 stored in the log 58 with theidentifiers and passwords 203 included in the data received from themonitor 12. If the identifiers 201 and passwords 202 match, the server54 stores the physiological data, such as ECG data, collected by themonitor as EMRs 51 associated with a particular identifier 201.

The EMRs 51 are not associated with and the database 52 does not storeany patient identifying information, but are instead stored under theidentifier 201 of the patch 15 used to collect data in the EMRs. Byexcluding the patient identifying information and organizing the EMRs 51exclusively based on the identifiers 201, the database 52 the databaseeliminates the risk of violating particular laws regarding disclosure ofpatient identifying information since such information is not stored. Ina further embodiment, the database 52 can store information needed tocontact the patient or another authorized party, such as the phonenumber of the patient's doctor.

As mentioned above, the monitor 12 can collect multiple kinds ofphysiological data and thus the EMRs 51 can include diversephysiological data such as samples of the electrocardiographic data, anddata from other sensors of the monitor 12, such as air-flow data,actigraphy data, temperature data, though other kinds of data ispossible. Further, the server 54 can receive a filtered ECG traceprocessed using the application 30 on a user device and store the tracewith the EMR 51 associated with the identifier 201 of the patch used tocollect the ECG samples on which the trace is based.

Further, the server 54 can also implement an automated over-read program59 that conducts an automated over-read of the ECG trace generated basedon the data obtained by the monitor 12. Prior to the over-read, thetrace can be filtered using the software 30. In a further embodiment,the trace can undergo other kinds of processing prior to being subjectto the over-read. During the over-read, the program 59 compares featuresof the ECG trace, such as shape and position of the waves, to ECG tracefeatures known to be indicative of one or more conditions. For example,irregular distances between successive R waves (“R-to-R intervals”) inan ECG can be indicative of atrial fibrillation, one of the most commoncardiac arrhythmias that is caused by seemingly disorganized atrialdepolarizations without effective atrial contractions. By analyzing theR-to-R intervals in the ECG trace created based on theelectrocardiographic signals collected by the monitor, the program 59can detect a presence of a condition indicative of atrial fibrillation.Further, in addition to detecting of ECG characteristics indicative ofthe condition, the program 59 can generate a recommendation based on thedetected condition. The recommendation and other results of theover-read can be stored as part of the EMRs 51 associated with theidentifier 201 for the patch 15 that was used to collect thephysiological data used in the over-read. In a further embodiment, therecommendation can be provided to the patient 10, 11 or anotherauthorized party as an alert.

The recommendation can depend on the duration of the detected condition.For example, if the analysis of the R-R waves indicates that the patient10, 11 has been experiencing atrial fibrillation for more than an hour,the recommendation can be for the patient to take a dose of anappropriate medication, such as aspirin. Similarly, as prolonged atrialfibrillation can increase a risk of stroke, if the analysis of the R-Rwaves indicates that the patient has been experiencing atrialfibrillation for more a day or more, the recommendation can includevisiting a physician for elective cardioversion prior to the likelydevelopment of an atrial clot. Other kinds of indications are possible.Still other data can be part of the EMRs 51.

The server 51 further maintains a website 133 where the patient 10, 11or another authorized party can access the patient's EMRs. For example,the patient can use the mobile device 132 to scan the QR code 204, withthe EMRs corresponding to the supplied identifier being presented on awebpage that is a part of the website 133 through the mobile device 132.As mentioned above, the QR code 32 could be scanned using a separatescanner, such as a scanner (not shown) attached to the computer 50, withthe website being presented through the computer 50. Other devices canalso be used to access the website 133.

The monitor recorder 14 stores ECG data and other information in theflash memory 262 (shown in FIG. 9) using a proprietary format thatincludes data compression. As a result, data retrieved from a monitorrecorder 14 must first be converted into a format suitable for use bythird party post-monitoring analysis software. FIG. 22 is a flow diagramshowing a method 150 for offloading and converting ECG and otherphysiological data from a extended wear electrocardiography andphysiological sensor monitor 12 in accordance with one embodiment. Themethod 150 can be implemented in software and execution of the softwarecan be performed on a download station 44, which could be a programmeror other device, or a computer system, including a server 54 or personalcomputer 50, such as further described supra with reference to FIG. 20,as a series of process or method modules or steps. For convenience, themethod 150 will be described in the context of being performed by apersonal computer 50 or other connectable computing device (shown inFIG. 3) as middleware that converts ECG data and other information intoa format suitable for use by a third-party post-monitoring analysisprogram. Execution of the method 150 by a computer system would beanalogous mutatis mutandis.

Initially, the download station 44 is connected to the monitor recorder14 (step 151), such as by physically interfacing to a set of terminals45 on a paired receptacle 127 or by wireless connection, if available.The data stored on the monitor recorder 14, including ECG andphysiological monitoring data, other recorded data, and otherinformation are retrieved (step 152) over a hard link 48 using a controlprogram 49 (“Ctl”) or analogous application executing on a personalcomputer 50 or other connectable computing device.

The data retrieved from the monitor recorder 14 is in a proprietarystorage format and each datum of recorded ECG monitoring data, as wellas any other physiological data or other information, must be converted,so that the data can be used by a third-party post-monitoring analysisprogram. Each datum of ECG monitoring data is converted by themiddleware (steps 153-159) in an iterative processing loop. During eachiteration (step 153), the ECG datum is read (step 154) and, ifnecessary, the gain of the ECG signal is adjusted (step 155) tocompensate, for instance, for relocation or replacement of the electrodepatch 15 during the monitoring period. Filtering described below withreference to FIG. 21 can also optionally take place during step 155.

In addition, depending upon the configuration of the wearable monitor12, other physiological data (or other information), including patientevents, such as a fall, peak activity level, sleep detection, detectionof patient activity levels and states, and so on, may be recorded alongwith the ECG monitoring data. For instance, actigraphy data may havebeen sampled by the actigraphy sensor 264 based on a sensed eventoccurrence, such as a sudden change in orientation due to the patienttaking a fall. In response, the monitor recorder 14 will embed theactigraphy data samples into the stream of data, including ECGmonitoring data, that is recorded to the flash memory 262 by themicrocontroller 261. Post-monitoring, the actigraphy data is temporallymatched to the ECG data to provide the proper physiological context tothe sensed event occurrence. As a result, the three-axis actigraphysignal is turned into an actionable event occurrence that is provided,through conversion by the middleware, to third party post-monitoringanalysis programs, along with the ECG recordings contemporaneous to theevent occurrence. Other types of processing of the other physiologicaldata (or other information) are possible.

Thus, during execution of the middleware, any other physiological data(or other information) that has been embedded into the recorded ECGmonitoring data is read (step 156) and time-correlated to the time frameof the ECG signals that occurred at the time that the otherphysiological data (or other information) was noted (step 157). Finally,the ECG datum, signal gain adjusted, if appropriate, and otherphysiological data, if applicable and as time-correlated, are stored ina format suitable to the backend software (step 158) used inpost-monitoring analysis.

In a further embodiment, the other physiological data, if apropos, isembedded within an unused ECG track. For example, the SCP-ENG standardallows multiple ECG channels to be recorded into a single ECG record.The monitor recorder 14, though, only senses one ECG channel. The otherphysiological data can be stored into an additional ECG channel, whichwould otherwise be zero-padded or altogether omitted. The backendsoftware would then be able to read the other physiological data incontext with the single channel of ECG monitoring data recorded by themonitor recorder 14, provided the backend software implemented changesnecessary to interpret the other physiological data. Still other formsof embedding of the other physiological data with formatted ECGmonitoring data, or of providing the other physiological data in aseparate manner, are possible.

Processing continues (step 159) for each remaining ECG datum, afterwhich the processing loop is exited and execution terminates. Stillother operations and steps are possible.

While the invention has been particularly shown and described asreferenced to the embodiments thereof, those skilled in the art willunderstand that the foregoing and other changes in form and detail maybe made therein without departing from the spirit and scope.

What is claimed is:
 1. A computer-implemented system for secure physiological data collection and processing, comprising: an extended wear electrocardiography and physiological sensor monitor recorder, comprising: a sealed housing adapted to be removably secured into a non-conductive receptacle on a disposable extended wear electrode patch, wherein an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch are stored on the patch; and an electronic circuitry comprised within the sealed housing, comprising: an electrocardiographic front end circuit electrically interfaced to an externally-powered micro-controller and operable to sense electrocardiographic signals through electrocardiographic electrodes provided on the disposable extended wear electrode patch when the sealed housing is secured within the non-conductive receptacle of the patch, wherein each of the electrocardiographic electrodes are adapted to be positioned axially along the midline of a sternum for capturing action potential propagation; the externally-powered micro-controller electrically interfaced to the front end and operable to execute under micro programmable control through firmware that is stored in a program memory unit of the micro-controller, the micro-controller operable to retrieve the password and the identifier from the patch when the sealed housing is secured within the non-conductive receptacle of the patch; and an externally-powered flash memory electrically interfaced with the micro-controller and operable to store together the password, the identifier, and samples of the electrocardiographic signals, the micro-controller further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier.
 2. A system according to claim 1, wherein the password stored on the patch is encoded using a secret key and the micro-controller decodes the password using the secret key.
 3. A system according to claim 1, wherein one or more of: the identifier comprises a serial number; and the password comprises a hash of the serial number or a part thereof.
 4. A system according to claim 1, further comprising: a secure database interconnected to a data communications network and operable to maintain data collected using the patch associated with the identifier, the data comprising the samples of the electrocardiographic signals received from the monitor recorder; a server coupled to the database and configured to maintain a webpage on the data communications network, the webpage comprising the data; a barcode comprising an encoding of the address of the webpage, the password, and the identifier; and a user device comprising a scanner operable to scan the barcode, the user device operable to access the webpage using the scan.
 5. A system according to claim 4, further comprising: one or more labels on which the barcode is comprised, the label further comprising one or more of the identifier and the password.
 6. A system according to claim 4, wherein the data displayed on the webpage comprises a report generated based on the samples of the electrocardiographic signals.
 7. A system according to claim 4, further comprising: a download station configured to receive the offloaded password, identifier, and samples of the electrocardiographic signals from the memory and to provide the received password, identifier, and samples to the server, wherein the server stores the samples in the database based on the provided password and identifier.
 8. A system according to claim 4, further comprising: a log of issued identifiers and issued passwords associated with the issued identifiers, the log stored in the database; a receipt module comprised in the server and configured to receive the password and the identifier scanned using the scanner from the barcode and to compare the received password and the identifier to one or more of the issued passwords and the issued identifiers in the log; a webpage module comprised in the server configured to provide the webpage to the user device based on the comparison.
 9. A system according to claim 4, further comprising: an over-read module comprised in the server and configured to perform an automated over-read of an ECG trace generated based on the samples of the electrocardiographic signals; and a recommendation module comprised in the server and configured to generate a recommendation based on the over-read.
 10. A system according to claim 4, wherein the user device is associated with a patient whose electrocardiographic signals were sensed and the user device is operable to present the webpage to the patient.
 11. A computer-implemented system for secure low amplitude cardiac action potential data collection and processing, comprising: a disposable extended wear electrode patch comprising: a flexible backing comprising stretchable material defined as an elongated strip with a narrow longitudinal midsection, each end of the flexible backing comprising an adhesive contact surface adapted to serve as a crimp relief; a pair of electrocardiographic electrodes comprised on the contact surface of each end of the flexible backing, each electrocardiographic electrode conductively exposed for dermal adhesion and adapted to be positioned axially along the midline of a sternum for capturing action potential propagation; a non-conductive receptacle affixed to a non-contacting surface of the flexible backing and comprising an electro mechanical docking interface; a pair of flexible circuit traces affixed at each end of the flexible backing with each circuit trace connecting one of the electrocardiographic electrodes to the docking interface, at least one of the circuit traces adapted to extend along the narrow longitudinal midsection to serve as a strain relief; and a circuit operable to store an identifier associated with the patch and a password for accessing results of a physiological monitoring conducted using the patch; and an ambulatory electrocardiography monitor comprising: a wearable housing adapted to securely fit into the receptacle; and electronic circuitry provided within the wearable housing and comprising an external interface configured to be removably connected to the electrocardiographic electrodes via the docking interface, further comprising: a low power microcontroller operable to execute over an extended period under modular micro program control as specified in firmware and further operable to retrieve the identifier and the password from the circuit when the wearable housing is secured within the non-conductive receptacle of the patch; an electrocardiographic front end circuit under the control of the microcontroller adapted to sense cardiac electrical potential differentials through the electrocardiographic electrodes, which are provided to the microcontroller as electrocardiographic signals representative of amplitudes of the action potential propagation; and a non-volatile memory electrically interfaced with the microcontroller and operable to continuously store samples of the electrocardiographic signals collected throughout the extended period together with the retrieved password and identifier, the micro-controller is further configured to offload the stored samples of the electrocardiographic signals from the memory together with the stored password and identifier.
 12. A system according to claim 11, wherein the password stored on the patch is encoded using a secret key and the micro-controller decodes the password using the secret key.
 13. A system according to claim 11, wherein one or more of: the identifier comprises a serial number; and the password comprises a hash of the serial number.
 14. A system according to claim 11, further comprising: a secure database interconnected to a data communications network and operable to maintain data collected using the patch associated with the identifier, the data comprising the samples of the electrocardiographic signals received from the monitor recorder; a server coupled to the database and configured to maintain a webpage on the data communications network, the webpage comprising the data; a barcode comprising an encoding of the address of the webpage, the password, and the identifier; and a user device comprising a scanner operable to scan the barcode, the user device operable to access the webpage using the scan.
 15. A system according to claim 14, further comprising: one or more labels on which the barcode is comprised, the label further comprising one or more of the identifier and the password.
 16. A system according to claim 14, wherein the data displayed on the webpage comprises a report generated based on the samples of the electrocardiographic signals.
 17. A system according to claim 14, further comprising: a download station configured to receive the offloaded password, identifier, and samples of the electrocardiographic signals from the memory and to provide the received password, identifier, and samples to the server wherein the server stores the samples in the database based on the provided password and identifier.
 18. A system according to claim 14, further comprising: a log of issued identifiers and issued passwords associated with the issued identifiers, the log stored in the database; and a receipt module comprised in the server and configured to receive the password and the identifier scanned using the scanner from the barcode and to compare the received password and identifier to one or more of the issued passwords and the issued identifiers in the log; a webpage module comprised in the server configured to provide the webpage to the user device based on the comparison.
 19. A system according to claim 14, further comprising: an over-read module comprised in the server and configured to perform an automated over-read of an ECG trace generated based on the samples of the electrocardiographic signals; and a recommendation module comprised in the server and configured to generate a recommendation based on the over-read.
 20. A system according to claim 19, wherein the ECG trace is filtered prior to the over-read being performed. 